Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery

NCT ID: NCT01303250

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-04-30

Brief Summary

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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

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Conditions

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Surgery, Colorectal

Keywords

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goal-directed fluid optimization hemodynamic optimization crystalloid colloid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

A balanced hydroxyethyl starch 130/0.4 will be used

Group Type EXPERIMENTAL

balanced 6% hydroxyethylstarch 130/0.4

Intervention Type DRUG

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

Group 2

A balanced crystalloid will be used

Group Type ACTIVE_COMPARATOR

balanced crystalloid

Intervention Type DRUG

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

Interventions

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balanced 6% hydroxyethylstarch 130/0.4

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

Intervention Type DRUG

balanced crystalloid

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Kabi

INDUSTRY

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugo Van Aken, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Intensive Care, University Hospital Muenster

Locations

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University Hospital Muenster

Münster, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2009-017595-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

04-AnIt-09

Identifier Type: OTHER

Identifier Source: secondary_id

UKM09_0031

Identifier Type: -

Identifier Source: org_study_id