Colorectal CarcinomaPhase 4HOCNCT01175317

Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum

A Phase 4 study testing Goal-directed fluid optimization and Regimen based on expertise anaesthesist in people with Colorectal Carcinoma, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Carcinoma
What is being tested?: Goal-directed fluid optimization and Regimen based on expertise anaesthesist
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteNetherlands
Study dates: Apr 2010to Oct 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

University Hospital Maastricht
Maastricht, Limburg, 6229 HX

Other trials in Netherlands

About this study

Official title: Does Hemodynamic Optimization During and After Colorectal Surgery Result in Improved Intestinal Perfusion, Sustained Intestinal Barrier and Improved Postoperative Recovery?

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.

Conditions: Colorectal Carcinoma
Being tested: Goal-directed fluid optimization, Regimen based on expertise anaesthesist
Keywords: Hemodynamic optimization, Enhanced recovery after surgery, Goal-directed fluid
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Goal-directed fluid optimizationProcedure or surgery
Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
Regimen based on expertise anaesthesistOther
Fluid regimen based on expertise anaesthesist

Study groups in NCT01175317
Study group	Role	What they receive
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. Receives: Procedure: Goal-directed fluid optimization
Regimen based on expertise anaesthesist	Other	Fluid regimen based on expertise anaesthesist Receives: Other: Regimen based on expertise anaesthesist

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 hour postoperatively

Secondary outcomes (1)

Average Intraoperative CO2 Gap
The CO2 gap (difference arterial pCO2 and pCO2 of the stomach lumen) reflects global intestinal perfusion status and is measured every 15 minutes intraoperatively and every 60 minutes during the first 8 hours postoperatively.
Intraoperative measurements were averaged per individual patient, producing the average intraoperative CO2 gap.
Measured: Average intraoperative CO2 gap

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Oct 2013

First posted4 Aug 2010 (estimated)
Study startApr 2010
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01175317
Sponsor's protocol ID: MEC 09-2-089
Acronym: HOC
Status last verified: May 2014
First submitted: 29 Jul 2010
Last updated: 19 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Hemodynamic Optimization During and After Colorectal Surgery Result in Improved Intestinal Perfusion, Sustained Intestinal Barrier and Improved Postoperative Recovery?
ClinicalTrials.gov ID: NCT01175317
Acronym / sponsor ID: HOC / MEC 09-2-089
Conditions: Colorectal Carcinoma
Keywords: Hemodynamic optimization, Enhanced recovery after surgery, Goal-directed fluid
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Maastricht University Medical CenterUniversity, hospital or other
Study start: Apr 2010
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 4 Aug 2010 (estimated)
Results: Posted 19 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Goal-directed fluid optimization	Experimental	Procedure: Goal-directed fluid optimizationFluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
Regimen based on expertise anaesthesist	Other	Other: Regimen based on expertise anaesthesistFluid regimen based on expertise anaesthesist

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Goal-directed fluid optimizationFluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.	Procedure or surgery	Goal-directed fluid optimization
Regimen based on expertise anaesthesistFluid regimen based on expertise anaesthesist	Other	Regimen based on expertise anaesthesist

Primary outcome

Peak Value of I-FABP
Time frame: 1 hour postoperatively
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 secondary outcome

Average Intraoperative CO2 Gap
Time frame: Average intraoperative CO2 gap

Results and safety

Results posted to the registry on 19 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Goal-directed Fluid Optimization	27	27
Regimen Based on Expertise Anaesthesist	31	31

Primary outcome: Peak Value of I-FABP

Time frame: 1 hour postoperatively. Mean (Standard Deviation). Unit: pg/mL

Measure	Goal-directed Fluid Optimization n = 27	Regimen Based on Expertise Anaesthesist n = 31
Value	440.8 (251.6)	522.4 (759.9)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Goal-directed Fluid Optimization	0 of 27 (0%)	0 of 27 (0%)	Not reported
Regimen Based on Expertise Anaesthesist	0 of 31 (0%)	0 of 31 (0%)	Not reported

Limitations and caveats (from the sponsor): Tolerance of esophageal Doppler probe postoperatively was low. Therefore, optimization based on cardiac output could only be achieved within 3 hours in most patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Colorectal Carcinoma

Not yet recruitingPhase 1
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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maarten F Von Meyenfeldt, MD, PhD study director

Maastricht University Medical Center

Martijn Poeze, MD, PhD study director

Maastricht University Medical Center

Geerard L Beets, MD, PhD study director

Maastricht University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Value of I-FABP (time frame: 1 hour postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01175317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014.