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Improvement of fluid balance in patients undergoing surgery of the colon and rectum.


- candidate number6824
- NTR NumberNTR2147
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2009
- Secondary IDs 09-2-089 MEC Academisch ziekenhuis Maastricht
- Public TitleImprovement of fluid balance in patients undergoing surgery of the colon and rectum.
- Scientific TitleDoes hemodynamic optimization during and after colorectal surgery result in improved intestinal perfusion, sustained intestinal barrier and improved postoperative recovery?
- ACRONYMHemodynamic optimization in colorectal surgery
- hypothesisHemodynamic optimization during and after colorectal surgery results in improved intestinal perfusion, sustained intestinal barrier and improved postoperative recovery.
- Healt Condition(s) or Problem(s) studiedHemodynamic optimization, Intestinal damage, ERAS, Gastrointestinal disease
- Inclusion criteria1. All patients undergoing elective colorectal surgery with anastomosis;
2. Minimum age 18 years;
3. Giving informed consent.
- Exclusion criteria1. Other causes of intestinal damage: IBD, occlusive disease;
2. Steroid use;
3. Esophageal varices and other esophageal disease;
4. Aortic valve disease.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate1-feb-2011
- Target number of participants58
- InterventionsFluid 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.
- Primary outcomeIntestinal Fatty Acid Binding Protein (I-FABP) in plasma and urine.
- Secondary outcome1. 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.
- Timepoints1. 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Kostan Reisinger
- CONTACT for SCIENTIFIC QUERIES Kostan Reisinger
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Profileringsfonds, azM
- PublicationsN/A
- Brief summary58 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.
- Main changes (audit trail)
- RECORD22-dec-2009 - 14-jan-2010


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