The significance of intestinal edema in sepsis

• Conditions: sepsis, severe sepsis, septic shock, blood poisoning; R65.0; R65.1; R57.2; Systemic Inflammatory Response Syndrome of infectious origin without organ failure; Systemic Inflammatory Response Syndrome of infectious origin with organ failure; Septic shock

• Registration Number: DRKS00010196
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 170

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total wall thickness (TWT).<br>Day 0, day 3 and day 5 after patient enrollment.<br>Endoscopic ultrasound (EUS).

Secondary Outcome Measures

Name	Time	Method
a) Severity of the disease. Day 0 to 5 (daily) after patient enrollment. SOFA-Score.<br>b) Incidence of surgery. Day 0 to 5 (daily) after patient enrollment. +/-.<br>c) Incidence of death. Day 0 to 5 (daily) after patient enrollment; At the day of ICU discharge; At day 30after patient enrollment. +/-.<br>d) Intestinal motility. Day 0 to 5 (daily) after patient enrollment. Residual gastric volume; intensity of bowel sounds; time delay to first faecal evacuation.<br>e) Fluid balance. Day 0 to 5 (daily) after patient enrollment. Calculation of balance from intake/output.<br>f) Colloidosmotic pressure. Day 0 to 5 (daily) after patient enrollment. Oncometry.<br>g) Impairment of mucosal perfusion. Day 0 to 5 (daily) after patient enrollment. Time-to-peak and AUC analysis.