rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) (PROTECT-CS)
2026. május 29. frissítette: China National Center for Cardiovascular Diseases
Perioperative Recombinant Human Brain Natriuretic Peptide for Renal Protection in Cardiac Surgery: the PROTECT-CS Randomized Clinical Trial
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a common and serious perioperative complication, independently associated with prolonged hospitalization, increased mortality, and progression to chronic kidney disease. Despite advances in surgical techniques and postoperative care, no widely accepted pharmacological prevention strategy exists.
Recombinant human brain natriuretic peptide (rhBNP) exerts vasodilatory, diuretic, and natriuretic effects, reduces cardiac preload and afterload, and has demonstrated safety and efficacy in treating congestive heart failure. Preliminary studies suggest rhBNP may reduce postoperative serum creatinine, increase urine output, and improve renal outcomes; however, large-scale randomized controlled evidence is lacking.
The PROTECT-CS trial is a multicenter, prospective, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of perioperative continuous intravenous rhBNP infusion (0.01 μg/kg/min for 48 ± 2 hours) for prevention of AKI in high-risk patients undergoing cardiac surgery with cardiopulmonary bypass. A total of 694 participants will be enrolled across 7 centers in China.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Beavatkozás / kezelés
Részletes leírás
Acute kidney injury (AKI) is one of the most common and serious complications following cardiac surgery. CSA-AKI is independently associated with short-term adverse outcomes including prolonged ICU stay, increased need for renal replacement therapy, and in-hospital mortality, as well as long-term consequences including progression to chronic kidney disease and elevated cardiovascular mortality. Despite extensive research efforts, current clinical management of CSA-AKI remains largely supportive, and no pharmacological intervention has been established as a standard preventive strategy in international guidelines.
Recombinant human brain natriuretic peptide (rhBNP, generic name: nesiritide) shares structural and biological activity highly similar to endogenous BNP. Its pharmacological properties include arterial and venous vasodilation, promotion of natriuresis and diuresis, reduction of cardiac preload and afterload, and direct improvement of glomerular filtration rate without adversely affecting serum potassium or creatinine. rhBNP has been widely used in Chinese cardiac surgery and critical care centers for perioperative hemodynamic optimization. Published small-sample randomized trials and a recent meta-analysis have suggested potential renal protective benefits of perioperative rhBNP in cardiac surgery patients; however, these studies were limited by small sample sizes, heterogeneous populations, and the use of renal endpoints as exploratory rather than primary outcomes.
The PROTECT-CS trial aims to address this evidence gap. Eligible participants are adults aged ≥18 years scheduled for elective cardiac surgery under cardiopulmonary bypass who have at least one AKI risk factor (age ≥70 years, preoperative renal impairment, type 2 diabetes mellitus, or heart failure). Participants will be randomized 1:1 using a central IWRS system, stratified by study center with a block size of 6, to receive either continuous intravenous rhBNP at 0.01 μg/kg/min or an equivalent volume of normal saline (placebo), initiated from anesthetic induction to the onset of cardiopulmonary bypass and continued for 48 ± 2 hours total. All participants receive standard perioperative care throughout.
The primary endpoint is the incidence of AKI diagnosed per KDIGO criteria within 7 days postoperatively. Secondary endpoints include AKI incidence within 72 hours, AKI duration and severity, need for renal replacement therapy during hospitalization, changes in renal function biomarkers, hemodynamic parameters, diuretic and vasoactive drug use, major adverse kidney events at 30 and 90 days (MAKE-30 and MAKE-90), 30-day all-cause mortality, ICU and hospital length of stay, and total hospitalization costs.
An independent Data Monitoring Committee (DMC) will conduct periodic safety reviews and a pre-planned interim analysis. Adverse drug reactions are graded per NCI-CTCAE Version 5.0. All study data are collected via an electronic data capture (EDC) system and managed in accordance with GCP standards.
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
694
Fázis
- 4. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Sheng Liu, MD
- Telefonszám: +86-10-88392313
- E-mail: liusheng@fuwai.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Heng Zhang, MD
- Telefonszám: +86-10-88322315
Tanulmányi helyek
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Beijing, Kína
- Fuwai Hospital, Chinese Academy of Medical Sciences
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Kapcsolatba lépni:
- Sheng Liu, MD
- Telefonszám: +86-10-88392313
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled (elective) cardiac surgery requiring cardiopulmonary bypass
- Presence of at least one of the following AKI risk factors:
- Age ≥ 70 years
- Preoperative renal impairment (eGFR ≤ 60 mL/min/1.73 m² or urine protein ≥ +2 at screening)
- Type 2 diabetes mellitus
- Heart failure, defined as NYHA Class II-IV with NT-proBNP ≥ 125 pg/mL at screening; for participants with atrial fibrillation, NT-proBNP ≥ 365 pg/mL is required
- Able to understand and provide written informed consent, and willing and able to comply with all study protocol requirements
Exclusion Criteria:
- Cardiogenic shock
- Severe hypotension (systolic blood pressure ≤ 90 mmHg) at screening
- Restrictive or obstructive cardiomyopathy, pericarditis, or cardiac tamponade
- Preoperative chronic kidney disease stage 4 or higher (eGFR < 30 mL/min/1.73 m²), or renal instability as judged by the investigator
- Known AKI diagnosed per KDIGO criteria within 48 hours prior to surgery
- Receipt of any form of renal replacement therapy within 30 days prior to surgery
- Use of ventricular assist device, intra-aortic balloon pump, or any other mechanical cardiac support device within 7 days prior to surgery
- Chronic hepatic insufficiency (Child-Pugh Class B or C) or hepatic dysfunction (ALT or AST > 2× upper limit of normal [ULN], or total bilirubin > 1.5× ULN)
- Active hepatitis B (HBsAg positive with HBV-DNA indicating active viral replication), active hepatitis C (HCV antibody positive with HCV-RNA indicating active viral replication), positive syphilis screen, known HIV infection, or positive HIV test
- Confirmed or treated endocarditis, sepsis, or active infection requiring antibiotic treatment within 30 days prior to surgery
- Requirement for aortic dissection repair, complex congenital heart surgery, emergency surgery, or life-saving surgery
- History of malignant tumor, solid tumor, metastatic tumor, or hematological malignancy within the past 5 years
- Prior organ transplantation or current use of immunosuppressive agents
- Any condition that may conflict with or contraindicate the use of intravenous vasodilator therapy
- Prior adverse reaction to nesiritide (recombinant BNP)
- Participation in any other clinical trial within 30 days prior to surgery
- Pregnant or breastfeeding women
- Any other condition that, in the judgment of the investigator, renders the participant unsuitable for study participation
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Négyszeres
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: rhBNP Treatment Group
Participants receive continuous intravenous infusion of recombinant human brain natriuretic peptide (rhBNP) at 0.01 μg/kg/min, initiated from anesthetic induction to the onset of cardiopulmonary bypass, administered continuously for 48 ± 2 hours.
All participants receive standard perioperative cardiac surgical care.
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Continuous intravenous infusion of rhBNP at 0.01 μg/kg/min, initiated at anesthetic induction and continued for 48 ± 2 hours.
The infusion rate is consistent with the approved dosage range in the drug prescribing information.
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Placebo Comparator: Placebo Control Group
Participants receive continuous intravenous infusion of normal saline at an equivalent rate and volume, initiated from anesthetic induction to the onset of cardiopulmonary bypass, administered continuously for 48 ± 2 hours.
All participants receive standard perioperative cardiac surgical care.
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Continuous intravenous infusion of normal saline at an equivalent volume and rate to the rhBNP arm, initiated at anesthetic induction and continued for 48 ± 2 hours.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Incidence of acute kidney injury (AKI) within 7 days postoperatively, diagnosed per KDIGO criteria
Időkeret: Within 7 days after surgery, or until hospital discharge if earlier
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AKI defined per KDIGO 2012 criteria as any of: (1) serum creatinine increase ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours; (2) serum creatinine increase to ≥ 1.5 times baseline within 7 days; or (3) urine output < 0.5 mL/kg/h for ≥ 6 consecutive hours.
If a participant is discharged earlier than postoperative day 7, AKI events occurring in-hospital are recorded.
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Within 7 days after surgery, or until hospital discharge if earlier
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Incidence of AKI within 72 hours postoperatively, diagnosed according to KDIGO criteria
Időkeret: Within 72 hours after surgery
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Within 72 hours after surgery
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Duration of AKI by KDIGO criteria
Időkeret: Within 7 days after surgery, or until hospital discharge if earlier
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Duration of AKI among participants who develop AKI within 7 days postoperatively, recorded in hours from onset to resolution per KDIGO criteria.
If a participant is discharged earlier than postoperative day 7, in-hospital AKI events are recorded.
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Within 7 days after surgery, or until hospital discharge if earlier
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Severity of AKI by KDIGO stage
Időkeret: Within 7 days after surgery, or until hospital discharge if earlier
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Distribution of participants across KDIGO Stage 1, Stage 2, and Stage 3, based on the maximum stage reached.
If a participant is discharged earlier than postoperative day 7, in-hospital AKI events are recorded.
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Within 7 days after surgery, or until hospital discharge if earlier
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Incidence of any form of renal replacement therapy (RRT) during the index hospitalization
Időkeret: During the index hospitalization
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Number of participants receiving any form of RRT (intermittent hemodialysis, continuous renal replacement therapy, or peritoneal dialysis) during the surgical hospitalization.
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During the index hospitalization
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Change in serum creatinine from preoperative baseline
Időkeret: 6, 24, 48, and 120 hours and 7 days after surgery
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Baseline defined as the last preoperative laboratory result.
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6, 24, 48, and 120 hours and 7 days after surgery
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Change in urinary creatinine from preoperative baseline
Időkeret: 6, 24, 48, and 120 hours and 7 days after surgery
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Baseline defined as the last preoperative laboratory result.
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6, 24, 48, and 120 hours and 7 days after surgery
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Change in estimated glomerular filtration rate (eGFR) from preoperative baseline
Időkeret: 6, 24, 48, and 120 hours and 7 days after surgery
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Baseline defined as the last preoperative laboratory result.
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6, 24, 48, and 120 hours and 7 days after surgery
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Change in pulmonary capillary wedge pressure (PCWP) from post-surgical baseline
Időkeret: 6, 12, 24, and 48 hours after surgery
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Baseline defined as the first measurement obtained after completion of surgery.
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6, 12, 24, and 48 hours after surgery
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Change in central venous pressure (CVP) from post-surgical baseline
Időkeret: 6, 12, 24, and 48 hours after surgery
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Baseline defined as the first measurement obtained after completion of surgery.
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6, 12, 24, and 48 hours after surgery
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Change in cardiac output (CO) from post-surgical baseline
Időkeret: 6, 12, 24, and 48 hours after surgery
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Baseline defined as the first measurement obtained after completion of surgery.
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6, 12, 24, and 48 hours after surgery
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Change in cardiac index (CI) from post-surgical baseline
Időkeret: 6, 12, 24, and 48 hours after surgery
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Baseline defined as the first measurement obtained after completion of surgery.
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6, 12, 24, and 48 hours after surgery
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Total intraoperative and postoperative diuretic dose
Időkeret: From anesthetic induction until hospital discharge
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Cumulative dose of diuretic agents administered intraoperatively and postoperatively, reported by drug.
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From anesthetic induction until hospital discharge
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Total intraoperative and postoperative inotrope dose
Időkeret: From anesthetic induction until hospital discharge
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Cumulative dose of inotropic agents administered intraoperatively and postoperatively, reported by drug.
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From anesthetic induction until hospital discharge
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Total intraoperative and postoperative vasopressor dose
Időkeret: From anesthetic induction until hospital discharge
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Cumulative dose of vasopressor agents administered intraoperatively and postoperatively, reported by drug.
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From anesthetic induction until hospital discharge
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Total intraoperative and postoperative vasodilator dose
Időkeret: From anesthetic induction until hospital discharge
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Cumulative dose of vasodilator agents administered intraoperatively and postoperatively, reported by drug.
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From anesthetic induction until hospital discharge
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Major Adverse Kidney Events at 30 days (MAKE-30)
Időkeret: 30 days after surgery
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Composite endpoint defined as the occurrence of any of the following: death from any cause, receipt of renal replacement therapy, or ≥25% decline in eGFR from baseline.
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30 days after surgery
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Major Adverse Kidney Events at 90 days (MAKE-90)
Időkeret: 90 days after surgery
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Composite endpoint defined as the occurrence of any of the following: death from any cause, receipt of renal replacement therapy, or ≥25% decline in eGFR from baseline.
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90 days after surgery
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All-cause mortality at 30 days
Időkeret: 30 days after surgery
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30 days after surgery
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Total ICU length of stay
Időkeret: Postoperative (From ICU admission until ICU discharge, an average of 3 days)
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Total ICU length of stay during the index hospitalization, calculated as the difference between ICU exit time and ICU admission time.
For participants with multiple ICU admissions, total ICU length of stay is the sum of all individual ICU stays.
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Postoperative (From ICU admission until ICU discharge, an average of 3 days)
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Postoperative hospital length of stay during the index hospitalization
Időkeret: Postoperative (From the day of surgery until hospital discharge, an average of 7 days)
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Postoperative hospital length of stay during the index hospitalization, calculated as the number of days from the date of surgery to the date of hospital discharge.
Days of hospitalization before surgery are not included.
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Postoperative (From the day of surgery until hospital discharge, an average of 7 days)
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Total postoperative medical costs during the index hospitalization
Időkeret: Postoperative (From the day of surgery until hospital discharge, an average of 7 days)
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Total postoperative medical costs during the index hospitalization, calculated as the sum of all itemized hospital charges incurred from the date of surgery to the date of hospital discharge (including but not limited to surgical fees, ICU fees, medications, laboratory tests, imaging, nursing care, and bed fees), extracted from the hospital information system (HIS) billing records.
Charges incurred before surgery are not included.
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Postoperative (From the day of surgery until hospital discharge, an average of 7 days)
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Együttműködők
Nyomozók
- Kutatásvezető: Sheng Liu, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerda J, Chawla LS. Global epidemiology and outcomes of acute kidney injury. Nat Rev Nephrol. 2018 Oct;14(10):607-625. doi: 10.1038/s41581-018-0052-0.
- Chen HH, Anstrom KJ, Givertz MM, Stevenson LW, Semigran MJ, Goldsmith SR, Bart BA, Bull DA, Stehlik J, LeWinter MM, Konstam MA, Huggins GS, Rouleau JL, O'Meara E, Tang WH, Starling RC, Butler J, Deswal A, Felker GM, O'Connor CM, Bonita RE, Margulies KB, Cappola TP, Ofili EO, Mann DL, Davila-Roman VG, McNulty SE, Borlaug BA, Velazquez EJ, Lee KL, Shah MR, Hernandez AF, Braunwald E, Redfield MM; NHLBI Heart Failure Clinical Research Network. Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial. JAMA. 2013 Dec 18;310(23):2533-43. doi: 10.1001/jama.2013.282190.
- Kellum JA, Romagnani P, Ashuntantang G, Ronco C, Zarbock A, Anders HJ. Acute kidney injury. Nat Rev Dis Primers. 2021 Jul 15;7(1):52. doi: 10.1038/s41572-021-00284-z.
- Jia P, Ji Q, Zou Z, Zeng Q, Ren T, Chen W, Yan Z, Shen D, Li Y, Peng F, Su Y, Xu J, Shen B, Luo Z, Wang C, Ding X. Effect of Delayed Remote Ischemic Preconditioning on Acute Kidney Injury and Outcomes in Patients Undergoing Cardiac Surgery: A Randomized Clinical Trial. Circulation. 2024 Oct 22;150(17):1366-1376. doi: 10.1161/CIRCULATIONAHA.124.071408. Epub 2024 Sep 25.
- Perez-Fernandez X, Ulsamer A, Camara-Rosell M, Sbraga F, Boza-Hernandez E, Moret-Ruiz E, Plata-Menchaca E, Santiago-Bautista D, Boronat-Garcia P, Gumucio-Sanguino V, Penafiel-Munoz J, Camacho-Perez M, Betbese-Roig A, Forni L, Campos-Gomez A, Sabater-Riera J; SIRAKI02 Study Group. Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial. JAMA. 2024 Nov 5;332(17):1446-1454. doi: 10.1001/jama.2024.20630.
- Landoni G, Monaco F, Ti LK, Baiardo Redaelli M, Bradic N, Comis M, Kotani Y, Brambillasca C, Garofalo E, Scandroglio AM, Viscido C, Paternoster G, Franco A, Porta S, Ferrod F, Calabro MG, Pisano A, Vendramin I, Barucco G, Federici F, Severi L, Belletti A, Cortegiani A, Bruni A, Galbiati C, Covino A, Baryshnikova E, Giardina G, Venditto M, Kroeller D, Nakhnoukh C, Mantovani L, Silvetti S, Licheri M, Guarracino F, Lobreglio R, Di Prima AL, Fresilli S, Labanca R, Mucchetti M, Lembo R, Losiggio R, Bove T, Ranucci M, Fominskiy E, Longhini F, Zangrillo A, Bellomo R; PROTECTION Study Group. A Randomized Trial of Intravenous Amino Acids for Kidney Protection. N Engl J Med. 2024 Aug 22;391(8):687-698. doi: 10.1056/NEJMoa2403769. Epub 2024 Jun 12.
- Shao J, Wang L, Shao C, Wang Y, Li J, Luo J, Du Z, Hou X. Effects of Perioperative Recombinant Human Brain Natriuretic Peptide in Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis. Rev Cardiovasc Med. 2025 Sep 18;26(9):36423. doi: 10.31083/RCM36423. eCollection 2025 Sep.
- Shehabi Y, Balachandran M, Al-Bassam W, Bailey M, Bellomo R, Bihari S, Brown A, Brown A, Collins D, Darlison PR, Li MA, Mandarano R, Sarode V, Pakavakis A; ALBICS AKI Study Investigators. Postoperative 20% Albumin Infusion and Acute Kidney Injury in High-Risk Cardiac Surgery Patients: The ALBICS AKI Randomized Clinical Trial. JAMA Surg. 2025 Aug 1;160(8):835-844. doi: 10.1001/jamasurg.2025.1683.
- Thielmann M, Corteville D, Szabo G, Swaminathan M, Lamy A, Lehner LJ, Brown CD, Noiseux N, Atta MG, Squiers EC, Erlich S, Rothenstein D, Molitoris B, Mazer CD. Teprasiran, a Small Interfering RNA, for the Prevention of Acute Kidney Injury in High-Risk Patients Undergoing Cardiac Surgery: A Randomized Clinical Study. Circulation. 2021 Oct 5;144(14):1133-1144. doi: 10.1161/CIRCULATIONAHA.120.053029. Epub 2021 Sep 3.
- Chen HH, Sundt TM, Cook DJ, Heublein DM, Burnett JC Jr. Low dose nesiritide and the preservation of renal function in patients with renal dysfunction undergoing cardiopulmonary-bypass surgery: a double-blind placebo-controlled pilot study. Circulation. 2007 Sep 11;116(11 Suppl):I134-8. doi: 10.1161/CIRCULATIONAHA.106.697250.
- Mentzer RM Jr, Oz MC, Sladen RN, Graeve AH, Hebeler RF Jr, Luber JM Jr, Smedira NG; NAPA Investigators. Effects of perioperative nesiritide in patients with left ventricular dysfunction undergoing cardiac surgery:the NAPA Trial. J Am Coll Cardiol. 2007 Feb 13;49(6):716-26. doi: 10.1016/j.jacc.2006.10.048. Epub 2006 Dec 11.
- Ejaz AA, Martin TD, Johnson RJ, Winterstein AG, Klodell CT, Hess PJ Jr, Ali AK, Whidden EM, Staples NL, Alexander JA, House-Fancher MA, Beaver TM. Prophylactic nesiritide does not prevent dialysis or all-cause mortality in patients undergoing high-risk cardiac surgery. J Thorac Cardiovasc Surg. 2009 Oct;138(4):959-64. doi: 10.1016/j.jtcvs.2009.05.014. Epub 2009 Jul 3.
- O'Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJ, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalan R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Mendez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Tang WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32-43. doi: 10.1056/NEJMoa1100171.
- Zarbock A, Forni L, Koyner JL, Gomez H, Pannu N, Ostermann M, Bellomo R, Kellum JA, von Groote T. Preventing acute kidney injury and its longer-term impact in the critically ill. Intensive Care Med. 2025 Jul;51(7):1331-1347. doi: 10.1007/s00134-025-08015-8. Epub 2025 Jul 15.
- Zarbock A, Weiss R, Albert F, Rutledge K, Kellum JA, Bellomo R, Grigoryev E, Candela-Toha AM, Demir ZA, Legros V, Rosenberger P, Galan Menendez P, Garcia Alvarez M, Peng K, Leger M, Khalel W, Orhan-Sungur M, Meersch M; EPIS-AKI Investigators. Epidemiology of surgery associated acute kidney injury (EPIS-AKI): a prospective international observational multi-center clinical study. Intensive Care Med. 2023 Dec;49(12):1441-1455. doi: 10.1007/s00134-023-07169-7. Epub 2023 Jul 28.
Hasznos linkek
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. május 1.
Elsődleges befejezés (Becsült)
2028. január 31.
A tanulmány befejezése (Becsült)
2029. július 31.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. május 14.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 29.
Első közzététel (Tényleges)
2026. június 1.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. június 1.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 29.
Utolsó ellenőrzés
2026. április 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2026-3155
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
De-identified individual participant data (IPD) underlying the results reported in the primary publication will be made available upon reasonable request, after approval by the principal investigator and data access committee, beginning 12 months after publication of the primary results and available for 36 months thereafter.
Data will be shared via a secure data transfer platform.
Requests should include a methodologically sound proposal and be directed to the principal investigator.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
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