중증이 아닌 심장 질환 환자에 대한 카디오펩티드 주사의 심장 보호 효과: 단일 기관 무작위 대조 시험
The study was a single-center, randomized controlled pilot study. To explore the cardioprotective effect of cardiopeptidin on non-heart disease patients with severe cardiac injury by comparing whether cardiopeptidin was used.
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Guangzhou, 중국, 510515
- Southern medical university Nanfang hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥18 years old
- The high-sensitive troponin T index was higher than the normal value during ICU hospitalization
- Obtain the informed consent of the subject or legal agent
Exclusion Criteria:
- Patients who are expected to die within 48 hours of ICU admission
- previous diagnosis of acute coronary syndrome, chronic cardiomyopathy, pulmonary heart disease, acute myocarditis, pericardial tamponade and other diseases that have been confirmed to cause myocardial injury
- cardiopulmonary resuscitation and/or electrical defibrillation before admission
- patients with acute ischemic stroke
- patients with stage 5 chronic kidney disease
- during pregnancy or breastfeeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Cardiopeptidin
Cardiopeptidin was administered intravenously once a day with 60mg of cardiopeptide for 3 days |
Cardiopeptidin was administered intravenously once a day with cardiopeptidin for 3 days.The dosing regimen follows the recommended dosage of 1 mg/kg/day as outlined in the product manual, with doses calculated based on the ideal body weight. |
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위약 비교기: 50 ml of normal saline intravenous infusion
50 ml of normal saline intravenous infusion. |
50 ml of normal saline intravenous infusion |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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major adverse cardiac events
기간: On the day of enrollment, until 28 days.
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major adverse cardiac events |
On the day of enrollment, until 28 days.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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28-day all-cause mortality
기간: 28-day
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28-day all-cause mortality |
28-day
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90-day all-cause mortality
기간: 90-day
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90-day all-cause mortality |
90-day
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Cardiac adverse events
기간: In hospital, until the patient is discharged.
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Cardiac adverse events |
In hospital, until the patient is discharged.
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LVEF
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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LVEF |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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APACHE II
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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APACHE II |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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Hypersensitive troponin T
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
|
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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MB
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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MB |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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NT-Pro BNP
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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NT-Pro BNP |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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LDH
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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LDH |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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α-HBDH
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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α-HBDH |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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CK
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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CK |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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CKMB
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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CKMB |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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Lac
기간: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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Lac |
On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: zhenhua zeng, Nanfang Hospital, Southern Medical University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NFEC-2023-060
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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