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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Regimen based on expertise anaesthesist | Other | Fluid regimen based on expertise anaesthesist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal-directed fluid optimization | Procedure | Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Average intraoperative CO2 gap |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Maastricht | Maastricht | Limburg | 6229 HX | Netherlands |
Patient inclusion rate was lower than expected. Main reason was unwillingness to participate, as extra nasal probes would remain in situ after surgery.
Inclusion period: july 2010 - october 2013 at single University Hospital: Maastricht University Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Regimen Based on Expertise Anaesthesist | Fluid regimen based on expertise anaesthesist |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Regimen Based on Expertise Anaesthesist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | pg/mL | 1 hour postoperatively |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Tolerance of esophageal Doppler probe postoperatively was low. Therefore, optimization based on cardiac output could only be achieved within 3 hours in most patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kostan Reisinger | Maastricht University Medical Center | 0031433881494 | k.reisinger@maastrichtuniversity.nl |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Regimen based on expertise anaesthesist | Other | Fluid regimen based on expertise anaesthesist |
|
Fluid regimen based on expertise anaesthesist
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | kPa | Average intraoperative CO2 gap |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Regimen Based on Expertise Anaesthesist | Fluid regimen based on expertise anaesthesist | 0 | 31 | 0 | 31 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |