NCT00517127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,109

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

10.3 years

First QC Date

August 15, 2007

Last Update Submit

January 8, 2018

Conditions

Fluid OverloadPostoperative Complications

Keywords

Intraoperative careRinger's lactateVoluvenCardiovascular diagnostic techniqueDoppler effect

Outcome Measures

Primary Outcomes (1)

  • combined perioperative morbidity

    30 days after surgery

Secondary Outcomes (1)

  • Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function,

    30 days after surgery

Other Outcomes (3)

  • Coagulation (ROTEM)

    intraop, postop day1

  • Inflammatory response attenuation by HES 130/0.4

    4 postoperative days

  • Body Composition Monitor Measurement (BCM)

    pre and postoperatively

Study Arms (2)

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

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

Interventions

Lactated Ringer's SolutionDRUG

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.

1
Hydroxyethylstarch 6% 130/0.4DRUG

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.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (15)

  • SHIRES T, WILLIAMS J, BROWN F. Acute change in extracellular fluids associated with major surgical procedures. Ann Surg. 1961 Nov;154(5):803-10. doi: 10.1097/00000658-196111000-00005. No abstract available.

    PMID: 13912109BACKGROUND

  • Shoemaker WC, Hauser CJ. Critique of crystalloid versus colloid therapy in shock and shock lung. Crit Care Med. 1979 Mar;7(3):117-24. doi: 10.1097/00003246-197903000-00007. No abstract available.

    PMID: 436427BACKGROUND

  • 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. doi: 10.1002/14651858.CD000567.pub2.

    PMID: 15495001BACKGROUND

  • Webb AR. Crystalloid or colloid for resuscitation. Are we any the wiser? Crit Care. 1999;3(3):R25-R28. doi: 10.1186/cc346. No abstract available.

    PMID: 11094479BACKGROUND

  • Boldt J. New light on intravascular volume replacement regimens: what did we learn from the past three years? Anesth Analg. 2003 Dec;97(6):1595-1604. doi: 10.1213/01.ANE.0000089961.15975.78.

    PMID: 14633526BACKGROUND

  • 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. doi: 10.1136/bmj.315.7113.909.

    PMID: 9361539BACKGROUND

  • 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. doi: 10.1001/archsurg.1995.01430040085019.

    PMID: 7535996BACKGROUND

  • 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. doi: 10.1097/00000542-200210000-00012.

    PMID: 12357146BACKGROUND

  • 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. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.

    PMID: 16155038BACKGROUND

  • 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. doi: 10.1002/bjs.5454.

    PMID: 16888706BACKGROUND

  • Horowitz PE, Kumar A. It's the colloid, not the esophageal Doppler monitor. Anesthesiology. 2003 Jul;99(1):238-9; author reply 239. doi: 10.1097/00000542-200307000-00045. No abstract available.

    PMID: 12826872BACKGROUND

  • 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. doi: 10.1097/00000539-199908000-00050.

    PMID: 10439777BACKGROUND

  • Obradovic M, Luf F, Reiterer C, Schoppmann S, Kurz A, Fleischmann E, Kabon B. The effect of goal-directed crystalloid versus colloid administration on postoperative spirometry parameters: a substudy of a randomized controlled clinical trial. Perioper Med (Lond). 2024 Apr 15;13(1):28. doi: 10.1186/s13741-024-00381-z.

    PMID: 38622671DERIVED

  • Obradovic M, Kurz A, Kabon B, Roth G, Kimberger O, Zotti O, Bayoumi A, Reiterer C, Stift A, Fleischmann E. The effect of intraoperative goal-directed crystalloid versus colloid administration on perioperative inflammatory markers - a substudy of a randomized controlled trial. BMC Anesthesiol. 2020 Aug 21;20(1):210. doi: 10.1186/s12871-020-01126-3.

    PMID: 32825817DERIVED

  • Reiterer C, Kabon B, Zotti O, Obradovic M, Kurz A, Fleischmann E. Effect of goal-directed crystalloid- versus colloid-based fluid strategy on tissue oxygen tension: a randomised controlled trial. Br J Anaesth. 2019 Dec;123(6):768-776. doi: 10.1016/j.bja.2019.08.027. Epub 2019 Oct 15.

    PMID: 31627889DERIVED

MeSH Terms

Conditions

EdemaPostoperative Complications

Interventions

Ringer's LactateHydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsStarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Edith Fleischmann, M.D., Ph.D.

    Department of Anesthesiology, University of Vienna Medical School, Vienna, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 16, 2007

Study Start

September 1, 2006

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

January 10, 2018

Record last verified: 2018-01

Locations

AU(1)