NCT01303250

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

4 years

First QC Date

February 22, 2011

Last Update Submit

December 17, 2015

Conditions

Surgery, Colorectal

Keywords

goal-directed fluid optimizationhemodynamic optimizationcrystalloidcolloid

Outcome Measures

Primary Outcomes (1)

  • Total amount of administered fluids

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

    intraoperatively

Secondary Outcomes (1)

  • Incidence of surgery related complications

    day 28 and 90 postoperatively

Study Arms (2)

Group 1

EXPERIMENTAL

A balanced hydroxyethyl starch 130/0.4 will be used

Drug: balanced 6% hydroxyethylstarch 130/0.4

Group 2

ACTIVE COMPARATOR

A balanced crystalloid will be used

Drug: balanced crystalloid

Interventions

balanced 6% hydroxyethylstarch 130/0.4DRUG

Fluid administration and optimization based on cardiac output findings during surgery.

Group 1
balanced crystalloidDRUG

Fluid administration and optimization based on cardiac output findings during surgery.

Group 2

Eligibility Criteria

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

You may qualify if:

  • patients undergoing elective colorectal surgery
  • minimum age 18 years
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Muenster

Münster, D-48149, Germany

Location

Study Officials

  • Hugo Van Aken, Prof. MD

    Department of Anesthesia and Intensive Care, University Hospital Muenster

    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
SPONSOR

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 24, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

DE(1)