rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) (PROTECT-CS)
2026年5月29日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
694
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sheng Liu, MD
- 電話番号：+86-10-88392313
- メール：liusheng@fuwai.com
研究連絡先のバックアップ
- 名前：Heng Zhang, MD
- 電話番号：+86-10-88322315
研究場所
-
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Beijing、中国
- Fuwai Hospital, Chinese Academy of Medical Sciences
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コンタクト：
- Sheng Liu, MD
- 電話番号：+86-10-88392313
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of acute kidney injury (AKI) within 7 days postoperatively, diagnosed per KDIGO criteria
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of AKI within 72 hours postoperatively, diagnosed according to KDIGO criteria
時間枠：Within 72 hours after surgery
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Within 72 hours after surgery
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Duration of AKI by KDIGO criteria
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：30 days after surgery
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30 days after surgery
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Total ICU length of stay
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Sheng Liu、Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- 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.
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便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月1日
一次修了 (推定)
2028年1月31日
研究の完了 (推定)
2029年7月31日
試験登録日
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
2026年5月29日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月29日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-3155
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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