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rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) (PROTECT-CS)

29 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

694

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

  • Nazwa: Heng Zhang, MD
  • Numer telefonu: +86-10-88322315

Lokalizacje studiów

  • Chiny
      • Beijing, Chiny
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Kontakt:
          • Sheng Liu, MD
          • Numer telefonu: +86-10-88392313

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Recombinant Human Brain Natriuretic Peptide (rhBNP)
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.
Komparator placebo: 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.
Lek: Normal Saline (Placebo)
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of acute kidney injury (AKI) within 7 days postoperatively, diagnosed per KDIGO criteria
Ramy czasowe: Within 7 days after surgery, or until hospital discharge if earlier
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.
Within 7 days after surgery, or until hospital discharge if earlier

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Incidence of AKI within 72 hours postoperatively, diagnosed according to KDIGO criteria
Ramy czasowe: Within 72 hours after surgery
Within 72 hours after surgery
Duration of AKI by KDIGO criteria
Ramy czasowe: Within 7 days after surgery, or until hospital discharge if earlier
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.
Within 7 days after surgery, or until hospital discharge if earlier
Severity of AKI by KDIGO stage
Ramy czasowe: Within 7 days after surgery, or until hospital discharge if earlier
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.
Within 7 days after surgery, or until hospital discharge if earlier
Incidence of any form of renal replacement therapy (RRT) during the index hospitalization
Ramy czasowe: During the index hospitalization
Number of participants receiving any form of RRT (intermittent hemodialysis, continuous renal replacement therapy, or peritoneal dialysis) during the surgical hospitalization.
During the index hospitalization
Change in serum creatinine from preoperative baseline
Ramy czasowe: 6, 24, 48, and 120 hours and 7 days after surgery
Baseline defined as the last preoperative laboratory result.
6, 24, 48, and 120 hours and 7 days after surgery
Change in urinary creatinine from preoperative baseline
Ramy czasowe: 6, 24, 48, and 120 hours and 7 days after surgery
Baseline defined as the last preoperative laboratory result.
6, 24, 48, and 120 hours and 7 days after surgery
Change in estimated glomerular filtration rate (eGFR) from preoperative baseline
Ramy czasowe: 6, 24, 48, and 120 hours and 7 days after surgery
Baseline defined as the last preoperative laboratory result.
6, 24, 48, and 120 hours and 7 days after surgery
Change in pulmonary capillary wedge pressure (PCWP) from post-surgical baseline
Ramy czasowe: 6, 12, 24, and 48 hours after surgery
Baseline defined as the first measurement obtained after completion of surgery.
6, 12, 24, and 48 hours after surgery
Change in central venous pressure (CVP) from post-surgical baseline
Ramy czasowe: 6, 12, 24, and 48 hours after surgery
Baseline defined as the first measurement obtained after completion of surgery.
6, 12, 24, and 48 hours after surgery
Change in cardiac output (CO) from post-surgical baseline
Ramy czasowe: 6, 12, 24, and 48 hours after surgery
Baseline defined as the first measurement obtained after completion of surgery.
6, 12, 24, and 48 hours after surgery
Change in cardiac index (CI) from post-surgical baseline
Ramy czasowe: 6, 12, 24, and 48 hours after surgery
Baseline defined as the first measurement obtained after completion of surgery.
6, 12, 24, and 48 hours after surgery
Total intraoperative and postoperative diuretic dose
Ramy czasowe: From anesthetic induction until hospital discharge
Cumulative dose of diuretic agents administered intraoperatively and postoperatively, reported by drug.
From anesthetic induction until hospital discharge
Total intraoperative and postoperative inotrope dose
Ramy czasowe: From anesthetic induction until hospital discharge
Cumulative dose of inotropic agents administered intraoperatively and postoperatively, reported by drug.
From anesthetic induction until hospital discharge
Total intraoperative and postoperative vasopressor dose
Ramy czasowe: From anesthetic induction until hospital discharge
Cumulative dose of vasopressor agents administered intraoperatively and postoperatively, reported by drug.
From anesthetic induction until hospital discharge
Total intraoperative and postoperative vasodilator dose
Ramy czasowe: From anesthetic induction until hospital discharge
Cumulative dose of vasodilator agents administered intraoperatively and postoperatively, reported by drug.
From anesthetic induction until hospital discharge
Major Adverse Kidney Events at 30 days (MAKE-30)
Ramy czasowe: 30 days after surgery
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.
30 days after surgery
Major Adverse Kidney Events at 90 days (MAKE-90)
Ramy czasowe: 90 days after surgery
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.
90 days after surgery
All-cause mortality at 30 days
Ramy czasowe: 30 days after surgery
30 days after surgery
Total ICU length of stay
Ramy czasowe: Postoperative (From ICU admission until ICU discharge, an average of 3 days)
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.
Postoperative (From ICU admission until ICU discharge, an average of 3 days)
Postoperative hospital length of stay during the index hospitalization
Ramy czasowe: Postoperative (From the day of surgery until hospital discharge, an average of 7 days)
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.
Postoperative (From the day of surgery until hospital discharge, an average of 7 days)
Total postoperative medical costs during the index hospitalization
Ramy czasowe: Postoperative (From the day of surgery until hospital discharge, an average of 7 days)
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.
Postoperative (From the day of surgery until hospital discharge, an average of 7 days)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

China National Center for Cardiovascular Diseases

Współpracownicy

Guangdong Provincial People's Hospital
Second Xiangya Hospital of Central South University
First Affiliated Hospital of Chongqing Medical University
Yantai Yuhuangding Hospital
The First Affiliated Hospital of Xiamen University
Shenzhen Sun Yat-sen Cardiovascular Hospital

Śledczy

  • Główny śledczy: Sheng Liu, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

31 stycznia 2028

Ukończenie studiów (Szacowany)

31 lipca 2029

Daty rejestracji na studia

Pierwszy przesłany

14 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2026

Pierwszy wysłany (Rzeczywisty)

1 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2026-3155

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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