Perioperative Colloid vs Crystalloid in Patients Undergoi... | NCT01303250

Studies
Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery

NCT01303250

Sponsor

University Hospital Muenster

Status

Terminated

Last Update Posted

Dec 18, 2015Estimated

Enrollment

31Actual

Phase

Phase 4

Conditions

Surgery, Colorectal

Interventions

balanced 6% hydroxyethylstarch 130/0.4
balanced crystalloid

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-017595-25	EudraCT Number
04-AnIt-09	Other Identifier	Department of Anesthesiology, University Hospital Muenster

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The final decision of the review of HES-containing solution shall be awaited.

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Feb 22, 2011

First Submission Date that Met QC Criteria

Feb 22, 2011

First Posted Date

Feb 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2015

Last Update Posted Date

Dec 18, 2015Estimated

Name	Class
Fresenius Kabi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
balanced 6% hydroxyethylstarch 130/0.4	Drug	Fluid administration and optimization based on cardiac output findings during surgery.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total amount of administered fluids	Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized	intraoperatively

Secondary Outcomes

Measure	Description	Time Frame
Incidence of surgery related complications		day 28 and 90 postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugo Van Aken, Prof. MD	Department of Anesthesia and Intensive Care, University Hospital Muenster	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Muenster		Münster		D-48149	Germany