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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01175317
First received: July 29, 2010
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: November 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Colorectal Carcinoma
Interventions: Procedure: Goal-directed fluid optimization
Other: Regimen based on expertise anaesthesist

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Inclusion period: july 2010 - october 2013 at single University Hospital: Maastricht University Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patient inclusion rate was lower than expected. Main reason was unwillingness to participate, as extra nasal probes would remain in situ after surgery.

Reporting Groups
  Description
Goal-directed Fluid Optimization 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 Anaesthesist Fluid regimen based on expertise anaesthesist

Participant Flow:   Overall Study
    Goal-directed Fluid Optimization     Regimen Based on Expertise Anaesthesist  
STARTED     27     31  
COMPLETED     27     31  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Goald-directed Fluid Optimization 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 Anaesthesist Fluid regimen based on expertise anaesthesist
Total Total of all reporting groups

Baseline Measures
    Goald-directed Fluid Optimization     Regimen Based on Expertise Anaesthesist     Total  
Number of Participants  
[units: participants]
  27     31     58  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     13     22  
>=65 years     18     18     36  
Age  
[units: years]
Mean ± Standard Deviation
  68.6  ± 10.8     67.6  ± 10.0     68.1  ± 10.3  
Gender  
[units: participants]
     
Female     6     11     17  
Male     21     20     41  
Region of Enrollment  
[units: participants]
     
Netherlands     27     31     58  



  Outcome Measures
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1.  Primary:   Peak Value of I-FABP   [ Time Frame: 1 hour postoperatively ]

2.  Secondary:   Average Intraoperative CO2 Gap   [ Time Frame: Average intraoperative CO2 gap ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Tolerance of esophageal Doppler probe postoperatively was low. Therefore, optimization based on cardiac output could only be achieved within 3 hours in most patients.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kostan Reisinger
Organization: Maastricht University Medical Center
phone: 0031433881494
e-mail: k.reisinger@maastrichtuniversity.nl


No publications provided


Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01175317     History of Changes
Other Study ID Numbers: MEC 09-2-089
Study First Received: July 29, 2010
Results First Received: November 5, 2013
Last Updated: May 19, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)