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Crystalloids Versus Colloids During Surgery (CC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517127
Recruitment Status : Completed
First Posted : August 16, 2007
Last Update Posted : January 10, 2018
Fresenius Kabi
Information provided by (Responsible Party):
Barbara Kabon, Medical University of Vienna

Brief Summary:
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 or disease Intervention/treatment Phase
Fluid Overload Postoperative Complications Drug: Lactated Ringer's Solution Drug: Hydroxyethylstarch 6% 130/0.4 Phase 4

Detailed Description:

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] .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management
Study Start Date : September 2006
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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.
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.

Active Comparator: 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.
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.

Primary Outcome Measures :
  1. combined perioperative morbidity [ Time Frame: 30 days after surgery ]

Secondary Outcome Measures :
  1. Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function, [ Time Frame: 30 days after surgery ]

Other Outcome Measures:
  1. Coagulation (ROTEM) [ Time Frame: intraop, postop day1 ]
    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.

  2. Inflammatory response attenuation by HES 130/0.4 [ Time Frame: 4 postoperative days ]

    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).

  3. Body Composition Monitor Measurement (BCM) [ Time Frame: pre and postoperatively ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517127

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Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Fresenius Kabi
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Principal Investigator: Edith Fleischmann, M.D., Ph.D. Department of Anesthesiology, University of Vienna Medical School, Vienna, Austria


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Barbara Kabon, MD, Medical University of Vienna Identifier: NCT00517127    
Other Study ID Numbers: 431/2005
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Keywords provided by Barbara Kabon, Medical University of Vienna:
Intraoperative care
Ringer's lactate
Cardiovascular diagnostic technique
Doppler effect
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes