Crystalloids Versus Colloids During Surgery (CC)

This study is currently recruiting participants.
Verified April 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: April 1, 2014
Last verified: April 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 ]

Estimated Enrollment: 400
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
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: April 1, 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:
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014