- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00517127
Crystalloids Versus Colloids During Surgery (CC)
A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management
연구 개요
상태
상세 설명
For a long time there is a raging debate whether crystalloid solutions or colloid solutions are better suited for fluid therapy. Early proponents both for crystalloids [Shires 1961] and colloids [Shoemaker 1979] deserve credit for elucidating important facts about volume replacement therapy - without answering the primary question. Elaborate reviews comparing crystalloid and colloid therapy for critically ill patients have been performed in the late nineties and updated recently [Roberts 2004]. However, it has been suggested that both questions and answers of reviews leave us none but wiser [Webb 1999]. Although a plethora of studies comparing crystalloid vs. colloid therapy in the last decades have been published, volume replacement therapy is still considered to be based on dogma and personal beliefs [Boldt 2003].
Goal-directed intraoperative fluid therapy monitored by Esophageal Doppler identifies volume-responders, thereby decreasing length of stay in hospital in orthopedic [Sinclair 1997], cardiac [Mythen 1995], and abdominal surgery patients [Gan 2002, Wakeling 2005, Noblett 2006]. However, all these studies have been performed with a colloid to be the substance applied. Thus, it has been questioned whether monitoring with the Esophageal Doppler monitor, or the application of additional colloid improved outcome [Horowitz, Kumar 2003].
Consequently, the researchers will use Esophageal Doppler Monitoring for intraoperative goal-directed fluid therapy to compare the effects of crystalloid vs. colloid therapy on various organ systems, assessing combined perioperative morbidity [Bennett-Guerrero 1999] .
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Vienna, 오스트리아, 1090
- Medical University of Vienna
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- After written informed consent patients undergoing elective open colon surgery, or open hysterectomy or myomectomy, or spine surgery or hip replacement will be included in the study.
Exclusion Criteria:
- Patients having severe cardiac or renal insufficiency
- Patients with severe coronary artery disease
- Patients with insulin-dependent diabetes mellitus
- Patients with severe COPD
- Patients with symptoms of infections or sepsis
- Patients with allergy to hydroxyethylstarch.
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: 1
Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.
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Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.
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활성 비교기: 2
Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.
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Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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combined perioperative morbidity
기간: 30 days after surgery
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30 days after surgery
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2차 결과 측정
결과 측정 |
기간 |
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Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function,
기간: 30 days after surgery
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30 days after surgery
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Coagulation (ROTEM)
기간: intraop, postop day1
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in a subgroup of 50 patients undergoing hepatic resection ROTEM measurements will be performed intraoperatively, postoperatively and on the first postoperative morning and compared between the groups.
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intraop, postop day1
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Inflammatory response attenuation by HES 130/0.4
기간: 4 postoperative days
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In a subgroups of 120 patients the postoperative immune function will be evaluated and compared between crystalloids and colloids. The immunological parameters include: IL6, IL-8, IL-10, Procalcitonin, lipopolysaccharide-binding protein, HLA-DR Expression, CRP C-reactive protein, leucocytes, TNF alpha Blood samples will be collected immediately before surgery (T0) for baseline measurement, immediately after surgery finish (T1), and on postoperative day one, two and four (T2, T3 and T4). |
4 postoperative days
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Body Composition Monitor Measurement (BCM)
기간: pre and postoperatively
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In a subgroup of 100 patients overhydration will be evaluated pre- and immediately postoperatively with a body composition monitor (BCM), a whole-body bioimpedance spectroscopy device manufactured and distributed by Fresenius Medical Care, Germany. Measurements will be compared betwwen the groups |
pre and postoperatively
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Edith Fleischmann, M.D., Ph.D., Department of Anesthesiology, University of Vienna Medical School, Vienna, Austria
간행물 및 유용한 링크
일반 간행물
- Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
- SHIRES T, WILLIAMS J, BROWN F. Acute change in extracellular fluids associated with major surgical procedures. Ann Surg. 1961 Nov;154(5):803-10. doi: 10.1097/00000658-196111000-00005. No abstract available.
- Shoemaker WC, Hauser CJ. Critique of crystalloid versus colloid therapy in shock and shock lung. Crit Care Med. 1979 Mar;7(3):117-24. doi: 10.1097/00003246-197903000-00007. No abstract available.
- Roberts I, Alderson P, Bunn F, Chinnock P, Ker K, Schierhout G. Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000567. doi: 10.1002/14651858.CD000567.pub2.
- Webb AR. Crystalloid or colloid for resuscitation. Are we any the wiser? Crit Care. 1999;3(3):R25-R28. doi: 10.1186/cc346. No abstract available.
- Boldt J. New light on intravascular volume replacement regimens: what did we learn from the past three years? Anesth Analg. 2003 Dec;97(6):1595-1604. doi: 10.1213/01.ANE.0000089961.15975.78.
- Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.
- Mythen MG, Webb AR. Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg. 1995 Apr;130(4):423-9. doi: 10.1001/archsurg.1995.01430040085019.
- Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
- Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.
- Noblett SE, Snowden CP, Shenton BK, Horgan AF. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection. Br J Surg. 2006 Sep;93(9):1069-76. doi: 10.1002/bjs.5454.
- Horowitz PE, Kumar A. It's the colloid, not the esophageal Doppler monitor. Anesthesiology. 2003 Jul;99(1):238-9; author reply 239. doi: 10.1097/00000542-200307000-00045. No abstract available.
- Obradovic M, Kurz A, Kabon B, Roth G, Kimberger O, Zotti O, Bayoumi A, Reiterer C, Stift A, Fleischmann E. The effect of intraoperative goal-directed crystalloid versus colloid administration on perioperative inflammatory markers - a substudy of a randomized controlled trial. BMC Anesthesiol. 2020 Aug 21;20(1):210. doi: 10.1186/s12871-020-01126-3.
- Reiterer C, Kabon B, Zotti O, Obradovic M, Kurz A, Fleischmann E. Effect of goal-directed crystalloid- versus colloid-based fluid strategy on tissue oxygen tension: a randomised controlled trial. Br J Anaesth. 2019 Dec;123(6):768-776. doi: 10.1016/j.bja.2019.08.027. Epub 2019 Oct 15.
연구 기록 날짜
연구 주요 날짜
연구 시작
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
기타 연구 ID 번호
- 431/2005
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. .
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