No registrations found.
ID
Source
Brief title
Health condition
Hemodynamic optimization, intestinal damage, ERAS, gastrointestinal disease.
Hemodynamische optimalisatie, intestinale schade, ERAS, gastrointestinale aandoeningen.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intestinal Fatty Acid Binding Protein (I-FABP) in plasma and urine.
Secondary outcome
1. C-reactive protein (CRP) in plasma;
2. Liver Fatty Acid Binding Protein (L-FABP) in plasma and urine;
3. CO2 gap (arterial pCO2 - pCO2 stomach lumen);
4. Postoperative complications.
Background summary
58 consecutive patients undergoing elective colorectal surgery are divided into two groups. The control group will receive standard care. The intervention group will receive standard care plus hemodynamic optimization based on in- or decrease of cardiac output. Between group differences are measured primarily by Intestinal Fatty Acid Binding Protein (I-FABP) in plasma and urine, an accurate marker of intestinal damage. Secundary outcome variables are plasma levels of CRP, plasma and urinary levels of Liver Fatty Acid Binding Protein (L-FABP, another marker of intestinal damage), and CO2 pressure in the stomach lumen (reflecting intestinal perfusion). We hypothesize that the intervention group will have less intestinal damage, improved intestinal perfusion and improved postoperative recovery compared to the control group.
Study objective
Hemodynamic optimization during and after colorectal surgery results in improved intestinal perfusion, sustained intestinal barrier and improved postoperative recovery.
Study design
1. Preoperative;
2. Every 15 minutes during surgery;
3. Every 60 minutes during the first 12 hours postoperatively;
4. Every 24 hours until discharge from hospital.
Intervention
Fluid and/or noradrenaline administration based on cardiac output in/decrease and mean arterial pressure.
The control group will receive standard care. The intervention group will receive standard care plus hemodynamic optimization based on in- or decrease of cardiac output.
Kostan Reisinger
Maastricht 6229 HX
The Netherlands
+31 (0)43 3882125
Kostan Reisinger
Maastricht 6229 HX
The Netherlands
+31 (0)43 3882125
Inclusion criteria
1. All patients undergoing elective colorectal surgery with anastomosis;
2. Minimum age 18 years;
3. Giving informed consent.
Exclusion criteria
1. Other causes of intestinal damage: IBD, occlusive disease;
2. Steroid use;
3. Esophageal varices and other esophageal disease;
4. Aortic valve disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2030 |
| NTR-old | NTR2147 |
| Other | MEC Academisch ziekenhuis Maastricht : 09-2-089 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |