Crystalloids Versus Colloids During Surgery (CC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Medical University of Vienna
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Barbara Kabon, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00517127
First received: August 15, 2007
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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
Fluid Therapy
Morbidity
Drug: Lactated Ringer's Solution
Drug: Hydroxyethylstarch 6% 130/0.4
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • combined perioperative morbidity [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function, [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Coagulation (ROTEM) [ Time Frame: intraop, postop day1 ] [ Designated as safety issue: No ]
    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.

  • Inflammatory response attenuation by HES 130/0.4 [ Time Frame: 4 postoperative days ] [ Designated as safety issue: No ]

    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).


  • Body Composition Monitor Measurement (BCM) [ Time Frame: pre and postoperatively ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 1112
Study Start Date: September 2006
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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] .

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517127

Contacts
Contact: Edith Fleischmann, M.D., Ph.D. +43-1-40400 6880 edith.fleischmann@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Edith Fleischmann, M.D.    +43-1-40400 6880    edith.fleischmann@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Fresenius Kabi
Investigators
Principal Investigator: Edith Fleischmann, M.D., Ph.D. Department of Anesthesiology, University of Vienna Medical School, Vienna, Austria
  More Information

Publications:

Responsible Party: Barbara Kabon, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00517127     History of Changes
Other Study ID Numbers: 431/2005
Study First Received: August 15, 2007
Last Updated: July 10, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Intraoperative care
Ringer's lactate
Voluven
Cardiovascular diagnostic technique
Doppler effect

Additional relevant MeSH terms:
Pharmaceutical Solutions
Hydroxyethyl Starch Derivatives
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes
Hematologic Agents

ClinicalTrials.gov processed this record on September 30, 2014