- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00456703
Restricted Fluid Regimen in Open Abdominal Bowel Surgery
Safety and Efficacy of Restricted Fluid Regimen in Open Abdominal Bowel Surgery
연구 개요
상세 설명
This is a randomized, prospective controlled trial in patients (ASA I-III) undergoing open abdominal surgical procedures in a single center. This study will be done in two phases. The first phase is designed to evaluate and prove the safety of restricted fluid regimens in maintaining tissue perfusion using a central venous oximetric catheter and arterial blood gas analysis. In the second phase of the study, we plan to mimic the usual clinical practice without the central venous oximetric catheter and arterial lines (invasive monitors) and the postoperative total morbidity will be compared between the liberal and restricted fluid regimens.
In the first phase of the study, 90 patients coming in for open bowel surgery will be randomized to three groups using a random number generator. All patients will receive a standard bowel prep regimen (Go-Lyte-half a liter the night before surgery). Group A will receive current standard of care (liberal fluid therapy), Group B and C will receive restricted fluid regimens. All patients will receive 500 cc of intravenous fluids (lactated ringers in Group A and B, 6% hetastarch in Group C) in the preoperative holding area to correct preoperative fluid deficits due to fasting and bowel preparation. Patients younger than 18 years, ASA IV or V, pregnant patients, those with coagulopathy, renal insufficiency, unstable angina, unstable congestive heart failure, and those with contraindication to central venous pressure catheter insertion will be excluded from the study.
After instituting anesthesia monitors, patients will be anesthetized with a standard anesthetic regimen. An arterial line and a central venous catheter with oximetric capability will be inserted in all three groups. A baseline blood gas will be drawn to note the base excess, lactate levels and the hematocrit at the start of surgery. Parameters like heart rate, blood pressure, central venous pressure, mixed venous oxygen saturation and arterial oxygen saturation and urine output will be continuously monitored. Both the regimens will be started in the operating room and continued into the postoperative period until they resume their oral intake. Patients in the liberal group will receive (10ml/kg/hr) the current standard of care for bowel surgery whereas those in the restricted group will receive 4ml/kg/hour. Post induction hemodynamic instability will be treated with ephedrine and phenylephrine at the discretion of the anesthesiologist in charge.
Intraoperative treatment of tachycardia, hypotension in both the groups will be treated using a standard fluid regimen algorithm (appendix A). All patients will receive the same postoperative fluid regimens as the current standard of care. Postoperative morbidity evaluation (appendix B) will be done at patient's discharge from the hospital. The data entry will be prospectively done during their hospital stay. The accuracy of the data will be checked by one of the study investigators.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ASA physical status I-III patients coming in for open abdominal bowel surgery
Exclusion Criteria:
- Coagulopathy,
- Pregnancy,
- Renal insufficiency,
- Contraindications for placing a central line,
- ASA IV and V,
- Age less than 18years
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: restriction
In this group, the fluids will be restricted compared to a standard procedure
|
fluid restriction
restriction of fluids
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
mixed venous oxygen saturation, acid bases, hemodynamics
기간: intraoperative period
|
intraoperative period
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Wound infection and length of hospital stay
기간: during the hospital admission
|
during the hospital admission
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Balachundhar Subramaniam, MD, Beth Israel Deaconess Medical Center
간행물 및 유용한 링크
일반 간행물
- Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
- Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. doi: 10.1097/00000542-200507000-00008.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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
기타 연구 ID 번호
- 2006P000144
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Bowel Surgery에 대한 임상 시험
-
Assistance Publique Hopitaux De Marseille완전한심혈관 질환 | 비만 환자 | Bariatric Surgery 전후의 이러한 TRL의 생성률프랑스
-
Dong Yang알려지지 않은복강경 보조 수술 | 절개 없는 복강경 전수술(Natural Orifice Transluminal Endoscopic Surgery, NOSES)중국
-
University Hospital, Strasbourg, France모병Cervico-Facial Surgery ENT 프랑스의 학술 의료 및 외과 교육 | Cervico-Facial Surgery ENT Medical 레지던트(Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine 및 Provence-Alpes-Côte d'Azur 지역)프랑스
intraoperative fluid management에 대한 임상 시험
-
Hadassah Medical OrganizationHebrew University of Jerusalem모병
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Nursing Research...완전한
-
Burst Biologics알려지지 않은
-
Nanogen, Inc.Centers for Disease Control and Prevention정지된
-
Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention완전한
-
Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention모병
-
naomi goldsteinNational Institute of Mental Health (NIMH)완전한