sepsis, severe sepsis, septic shock, blood poisoning R65.0 R65.1 R57.2
Conditions
Interventions
Group 1: septic patients, surgical (Standard care with no study related interventions)
Group 2: septic patients, non surgical (Standard care with no study related interventions)
Group 3: surgical pati
Sponsors
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Arm 1: septic patients, surgical. Detailed: patients treated in the intensive care unit for severe sepsis and main surgery; severe sepsis or septic shock since = 36h; main surgery since = 48h. Arm 2: septic patients, non surgical. Detailed: patients treated in the intensive care unit for severe sepsis; severe sepsis or septic shock since = 36h. Arm 3: surgical patients. Non septic. Detailed: patients treated in the intensive care unit after planned main surgery since = 36h; perioperative need for = 3000ml of fluids. Arm 4: healthy subjects undergoing routine endoscopy. Detailed: ambulant patients; planned examination of the upper and lower intestinal tract by endoscopy.
Exclusion criteria
Exclusion criteria: inflammatory bowel disease (active), chronic liver failure (Child-Pugh-Classification C) or HIV disease, identified portal hypertension, identified portal vein thrombosis, identified hepatosplenomegaly, immunosupression, bone marrow or hematopoietic stem cell transplantation within the last 12 month, pregnancy or lactation, enrollment in an interventional study (within the last 30 days), enrollment in this study before, best supportive care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total wall thickness (TWT). Day 0, day 3 and day 5 after patient enrollment. Endoscopic ultrasound (EUS). | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Severity of the disease. Day 0 to 5 (daily) after patient enrollment. SOFA-Score. b) Incidence of surgery. Day 0 to 5 (daily) after patient enrollment. +/-. c) Incidence of death. Day 0 to 5 (daily) after patient enrollment; At the day of ICU discharge; At day 30after patient enrollment. +/-. d) Intestinal motility. Day 0 to 5 (daily) after patient enrollment. Residual gastric volume; intensity of bowel sounds; time delay to first faecal evacuation. e) Fluid balance. Day 0 to 5 (daily) after patient enrollment. Calculation of balance from intake/output. f) Colloidosmotic pressure. Day 0 to 5 (daily) after patient enrollment. Oncometry. g) Impairment of mucosal perfusion. Day 0 to 5 (daily) after patient enrollment. Time-to-peak and AUC analysis. | — |
Countries
Germany
Contacts
Public ContactIngmar Lautenschläger
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
Outcome results
None listed