Colorectal Carcinoma
Conditions
Keywords
Hemodynamic optimization, Enhanced recovery after surgery, Goal-directed fluid
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.
Interventions
PROCEDUREGoal-directed fluid optimization
Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
OTHERRegimen based on expertise anaesthesist
Fluid regimen based on expertise anaesthesist
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients undergoing elective colorectal surgery with anastomosis; * Minimum age 18 years; * Giving informed consent.
Exclusion criteria
* Other causes of intestinal damage: eg. IBD, occlusive disease; * Steroid use; * Esophageal varices and other esophageal disease; * Aortic valve disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Value of I-FABP | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Intraoperative CO2 Gap | 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. |
Countries
Netherlands
Participant flow
Recruitment details
Inclusion period: july 2010 - october 2013 at single University Hospital: Maastricht University Medical Center.
Pre-assignment details
Patient inclusion rate was lower than expected. Main reason was unwillingness to participate, as extra nasal probes would remain in situ after surgery.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| Regimen Based on Expertise Anaesthesist Fluid regimen based on expertise anaesthesist | 31 |
| Total | 58 |
Baseline characteristics
| Characteristic | Regimen Based on Expertise Anaesthesist | Total | Goald-directed Fluid Optimization |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 36 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 22 Participants | 9 Participants |
| Age, Continuous | 67.6 years STANDARD_DEVIATION 10 | 68.1 years STANDARD_DEVIATION 10.3 | 68.6 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment Netherlands | 31 participants | 58 participants | 27 participants |
| Sex: Female, Male Female | 11 Participants | 17 Participants | 6 Participants |
| Sex: Female, Male Male | 20 Participants | 41 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 31 |
| serious Total, serious adverse events | 0 / 27 | 0 / 31 |
Outcome results
Primary
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.
Time frame: 1 hour postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal-directed Fluid Optimization | Peak Value of I-FABP | 440.8 pg/mL | Standard Deviation 251.6 |
| Regimen Based on Expertise Anaesthesist | Peak Value of I-FABP | 522.4 pg/mL | Standard Deviation 759.9 |
Secondary
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.
Time frame: Average intraoperative CO2 gap
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal-directed Fluid Optimization | Average Intraoperative CO2 Gap | -0.1 kPa | Standard Deviation 0.6 |
| Regimen Based on Expertise Anaesthesist | Average Intraoperative CO2 Gap | 0.4 kPa | Standard Deviation 0.5 |