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Restrictive or Doppler-guided Fluid Treatment in Colorectal Surgery

NCT03677622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-10-05

No results posted yet for this study

Summary

This is a clinical randomised double blinded multicentre trial of two different fluid treatments during colorectal surgery in an enhanced recovery programme A restricted fluid regimen aiming at zero fluid balance and less than two kilograms bodyweight change was compared with another fluid regimen where intravenous fluids were given to reach near maximal stroke volume of the heart, guided by a Doppler in the oesophagus.

The primary outcome was a composite outcome of postoperative complications and death.

Included was 150 patients undergoing elective colorectal surgery. No difference was found between the two groups. Both fluid therapies resulted in low complication rates. The difference in fluid volume between the groups was only 600 ml on the day of operation.

The results are published, see reference section.

Conditions

  • Fluid Overload

Interventions

DRUG

Voluven to near maximal stroke volume of the heart

Stroke volume guided fluid treatment with Voluven on the basis of restricted fluid therapy

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • Glostrup University Hospital, Copenhagen

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Svendborg Hospital

    collaborator OTHER

  • Holbaek Sygehus

    lead OTHER

Principal Investigators

  • Birgitte Brandstrup, PhD · Holbaek Sygehus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-01
Primary Completion
2009-07-31
Completion
2009-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03677622 on ClinicalTrials.gov