Starch or Saline After Cardiac Surgery (SSACS)
Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial
When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons:
- to compensate for no oral intake
- to support blood pressure and organ function during and after surgery
- to replace lost fluid or blood volume
There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation.
There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery.
The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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London, Ontario, 캐나다, N6A 5A5
- London Health Sciences Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients undergoing elective primary isolated on-pump coronary artery bypass grafting
Exclusion Criteria:
- pregnant patients
- patients with an active intra-cranial bleed
- patients with a history of hypersensitivity to starch solutions
- patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate < 30 ml / min / 1.73 m2)
- patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Starch group
Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.
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활성 비교기: Saline group
Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence of acute kidney injury as defined by RIFLE criteria
기간: Short term (in hospital, up to 30 days) and mid-term (2 months)
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Short term (in hospital, up to 30 days) and mid-term (2 months)
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Maximum postoperative weight gain
기간: Short-term (in hospital, up to 7 days)
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Short-term (in hospital, up to 7 days)
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Operative mortality
기간: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Duration of ventilation support requirements
기간: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Total chest tube drainage (until removed)
기간: In hospital (up to 30 days)
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In hospital (up to 30 days)
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ICU length of stay
기간: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Transfusion of blood products
기간: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Incidence of atrial fibrillation (necessitating a change in medical management)
기간: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Duration of oxygen supplementation
기간: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
기간: In hospital at defined timepoints, and at 2 months post hospital discharge
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In hospital at defined timepoints, and at 2 months post hospital discharge
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Volume of fluid infused
기간: In hospital (up to 7 days)
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In hospital (up to 7 days)
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Total hospital length of stay (when ready to leave tertiary hospital setting)
기간: In hospital
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In hospital
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공동 작업자 및 조사자
수사관
- 연구 책임자: Dave Nagpal, MD, LHSC / UWO
- 수석 연구원: Ray Guo, MD, LHSC / UWO
- 수석 연구원: Chris Harle, MD, LHSC / UWO
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- LHSC
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