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Crystalloids vs. Colloids During Surgery (CC)
This study is currently recruiting participants.
Verified by University Hospital Inselspital, Berne, August 2007
First Received: August 15, 2007   No Changes Posted
Sponsors and Collaborators: University Hospital Inselspital, Berne
Medical University of Vienna
Information provided by: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00517127
  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 IV

MedlinePlus related topics: Nausea and Vomiting Surgery
Drug Information available for: Ringer's lactate Ringer's solution
U.S. FDA Resources
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

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • combined perioperative morbidity [ Time Frame: within length of stay in hospital ]

Secondary Outcome Measures:
  • Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain [ Time Frame: within length of stay in hospital ]

Estimated Enrollment: 400
Study Start Date: September 2006
Estimated Study Completion Date: December 2009
Arms Assigned Interventions
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.
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.
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.
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, 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] .

  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: 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

Locations
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    
Sponsors and Collaborators
University Hospital Inselspital, Berne
Medical University of Vienna
Investigators
Principal Investigator: Gunther J. Pestel, M.D. Department of Anesthesiology, Bern University Hospital, Bern, Switzerland
  More Information

Publications:
SHIRES T, WILLIAMS J, BROWN F. Acute change in extracellular fluids associated with major surgical procedures. Ann Surg. 1961 Nov;154:803-10. 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. 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. Review.
Webb AR. Crystalloid or colloid for resuscitation. Are we any the wiser? Crit Care. 1999;3(3):R25-R28. 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):1595-604. Review.
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.
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.
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.
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. 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.
Horowitz PE, Kumar A. It's the colloid, not the esophageal Doppler monitor. Anesthesiology. 2003 Jul;99(1):238-9; author reply 239. No abstract available.
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.

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

Keywords provided by University Hospital Inselspital, Berne:
Intraoperative care
Ringer's lactate
Voluven
Cardiovascular diagnostic technique
Doppler effect

ClinicalTrials.gov processed this record on May 07, 2009