Trial Outcomes & Findings for Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum (NCT NCT01175317)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

58 participants

Primary outcome timeframe

1 hour postoperatively

Results posted on

2014-06-19

Participant Flow

Inclusion period: july 2010 - october 2013 at single University Hospital: Maastricht University Medical Center.

Patient inclusion rate was lower than expected. Main reason was unwillingness to participate, as extra nasal probes would remain in situ after surgery.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	27	31
Overall Study COMPLETED	27	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Goald-directed Fluid Optimization n=27 Participants 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 n=31 Participants Fluid regimen based on expertise anaesthesist	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Age, Continuous	68.6 years STANDARD_DEVIATION 10.8 • n=5 Participants	67.6 years STANDARD_DEVIATION 10.0 • n=7 Participants	68.1 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment Netherlands	27 participants n=5 Participants	31 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Goal-directed Fluid Optimization n=27 Participants 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 n=31 Participants Fluid regimen based on expertise anaesthesist
Peak Value of I-FABP	440.8 pg/mL Standard Deviation 251.6	522.4 pg/mL Standard Deviation 759.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Goal-directed Fluid Optimization n=27 Participants 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 n=31 Participants Fluid regimen based on expertise anaesthesist
Average Intraoperative CO2 Gap	-0.1 kPa Standard Deviation 0.6	0.4 kPa Standard Deviation 0.5

Adverse Events

Goal-directed Fluid Optimization

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regimen Based on Expertise Anaesthesist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kostan Reisinger

Maastricht University Medical Center

Phone: 0031433881494

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place