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Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery

Phase 4
Terminated
Conditions
Surgery, Colorectal
Interventions
Registration Number
NCT01303250
Lead Sponsor
University Hospital Muenster
Brief Summary

The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation \<= 12%.

The investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
31
Inclusion Criteria
  • patients undergoing elective colorectal surgery
  • minimum age 18 years
  • informed consent
Exclusion Criteria
  • patients with severe cardiomyopathy or severe heart failure
  • history of coagulation disorders
  • intracranial hemorrhage
  • patients with severe cardiovascular or respiratory disorders
  • renal insufficiency
  • severe liver diseases

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 2balanced crystalloidA balanced crystalloid will be used
Group 1balanced 6% hydroxyethylstarch 130/0.4A balanced hydroxyethyl starch 130/0.4 will be used
Primary Outcome Measures
NameTimeMethod
Total amount of administered fluidsintraoperatively

Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized

Secondary Outcome Measures
NameTimeMethod
Incidence of surgery related complicationsday 28 and 90 postoperatively

Trial Locations

Locations (1)

University Hospital Muenster

🇩🇪

Muenster, Germany

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