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Sponsors and Collaborators: |
University Hospital Inselspital, Berne Medical University of Vienna |
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Information provided by: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT00517127 |
The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. Goal-directed therapy is based on measurements by an Esophageal Doppler Device.
Condition | Intervention | Phase |
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Fluid Therapy Morbidity |
Drug: Lactated Ringer's Solution Drug: Hydroxyethylstarch 6% 130/0.4 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-Directed Fluid Management |
Estimated Enrollment: | 400 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
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1: Active Comparator
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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Drug: Lactated Ringer's Solution
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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2: Active Comparator
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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Drug: Hydroxyethylstarch 6% 130/0.4
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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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, we 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] .
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gunther J. Pestel, M.D. | +41-31-632 2111 | gunther.pestel@insel.ch |
Contact: Edith Fleischmann, M.D. | +43-1-40400 6880 | edith.fleischmann@meduniwien.ac.at |
Austria | |
Medical University of Vienna | Recruiting |
Vienna, Austria, 1090 | |
Contact: Edith Fleischmann, M.D. +43-1-40400 6880 edith.fleischmann@meduniwien.ac.at | |
Switzerland | |
University of Bern | Recruiting |
Bern, Switzerland, 3010 | |
Contact: Gunther J. Pestel, M.D. +41-31-632 2111 gunther.pestel@insel.ch |
Principal Investigator: | Gunther J. Pestel, M.D. | Department of Anesthesiology, Bern University Hospital, Bern, Switzerland |
Study ID Numbers: | UNIBE-KAS-0606-KEK-88/06-CC |
Study First Received: | August 15, 2007 |
Last Updated: | August 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00517127 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Intraoperative care Ringer's lactate Voluven Cardiovascular diagnostic technique Doppler effect |