Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery

Surgery, Colorectal Clinical Trial

— KoKris  

Official title:

Balanced 6 % HES 130/0.4 vs. Balanced Crystalloid-based Infusion in Patients Undergoing Colorectal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01303250
• Other study ID #: UKM09_0031
• Secondary ID: 2009-017595-2504
• Status: Terminated
• Phase: Phase 4
• First received: February 22, 2011
• Last updated: December 17, 2015
• Start date: April 2011
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgery, Colorectal

Intervention

Drug:
• balanced 6% hydroxyethylstarch 130/0.4
Fluid administration and optimization based on cardiac output findings during surgery.
• balanced crystalloid
Fluid administration and optimization based on cardiac output findings during surgery.

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Muenster

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of administered fluids	Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized	intraoperatively	No
Secondary	Incidence of surgery related complications		day 28 and 90 postoperatively	No