NCT01175317

Brief Summary

58 patients undergoing surgery of the large bowel are divided into two groups. The control group will receive standard care. The intervention group will receive standard care plus optimization of the blood circulation based on in- or decrease of the output of the heart. Between group differences are measured primarily by markers of intestinal damage in plasma and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the gut). The investigators hypothesize that the intervention group will have less intestinal damage, improved blood supply to the bowel and improved recovery of the operation compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 19, 2014

Completed
Last Updated

June 19, 2014

Status Verified

May 1, 2014

Enrollment Period

3.5 years

First QC Date

July 29, 2010

Results QC Date

November 5, 2013

Last Update Submit

May 19, 2014

Conditions

Colorectal Carcinoma

Keywords

Hemodynamic optimizationEnhanced recovery after surgeryGoal-directed fluid

Outcome Measures

Primary Outcomes (1)

  • Peak Value of I-FABP

    Intestinal-Fatty Acid Binding Protein (a marker of intestinal damage) is measured in plasma. The primary outcome measure is the difference in peak values of I-FABP between the control group and the intervention group.

    1 hour postoperatively

Secondary Outcomes (1)

  • Average Intraoperative CO2 Gap

    Average intraoperative CO2 gap

Study Arms (2)

Goal-directed fluid optimization

EXPERIMENTAL

Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.

Procedure: Goal-directed fluid optimization

Regimen based on expertise anaesthesist

OTHER

Fluid regimen based on expertise anaesthesist

Other: Regimen based on expertise anaesthesist

Interventions

Goal-directed fluid optimizationPROCEDURE

Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.

Goal-directed fluid optimization
Regimen based on expertise anaesthesistOTHER

Fluid regimen based on expertise anaesthesist

Regimen based on expertise anaesthesist

Eligibility Criteria

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

You may qualify if:

  • All patients undergoing elective colorectal surgery with anastomosis;
  • Minimum age 18 years;
  • Giving informed consent.

You may not qualify if:

  • Other causes of intestinal damage: eg. IBD, occlusive disease;
  • Steroid use;
  • Esophageal varices and other esophageal disease;
  • Aortic valve disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Limitations and Caveats

Tolerance of esophageal Doppler probe postoperatively was low. Therefore, optimization based on cardiac output could only be achieved within 3 hours in most patients.

Results Point of Contact

Title
Kostan Reisinger
Organization
Maastricht University Medical Center
k.reisinger@maastrichtuniversity.nl
0031433881494

Study Officials

  • Maarten F Von Meyenfeldt, MD, PhD

    Maastricht University Medical Center

    STUDY DIRECTOR

  • Martijn Poeze, MD, PhD

    Maastricht University Medical Center

    STUDY DIRECTOR

  • Geerard L Beets, MD, PhD

    Maastricht University Hospital

    STUDY DIRECTOR

  • Wim A Buurman, PhD

    Maastricht University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2010

First Posted

August 4, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

June 19, 2014

Results First Posted

June 19, 2014

Record last verified: 2014-05

Locations

NL(1)