Individualized analysis of the metabolism in critically ill patients with sepsis

• Conditions: Systemic Inflammatory Response Syndrome of infectious origin with organ failure; Septic shock; sepsis, septic shock; R65.1; R57.2

• Registration Number: DRKS00008582
• 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: 2016-10-20
• Study Completion: 2021-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Presence of sepsis or septic shock* and
- onset of sepsis or septic shock = 48 hours
- adult female and male patients (age = 18 years)
- written informed consent by the patient or her/his legal representative

*Definition of sepsis according to Sepsis-3 criteria of the Sepsis Definitions Task Force:
• Evidence or suspicion of infection (Clinical, Laboratory):
- Temperature, white blood cell count, heart rate, biomarker
- Microbiology
- Antibiotic treatment
• ? SOFA-Score = 2: PaO2/FiO2, platelet count, bilirubin, mean arterial blood pressure (MAP), catecholamines, Glasgow-Coma-Score, creatinine, urine output
• Septic shock defined as a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP = 65 mmHg and a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation

Exclusion Criteria

1. Preexisting chronic liver disease Child-Pugh-Class C
2. Absolute contraindication to enteral nutrition (e.g., gastrointestinal [GI] perforation, obstruction or no GI tract access for any reason)
3. Immunosupression or therapy with corticosteroids above cushing-limit (>7.5 mg prednisiolone equivalent)
4. Preexisting acute pancreatitis
5. Women during pregnancy or lactating women
6. Previous participation in this study
7. Limitation of therapy or coded Do-not-resuscitate
8. Infaust prognosis due to comorbid condition

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint ist the change in metabolome, transcriptome, marker of autophagy/ER stress response, inflammation and microbiome before and 2 hours after the daily start of parenteral glucose infusion over the course of the first 5 days and study day 10 (or ICU discharge respectively in case the event occurs before day 10). Primary endpoint of the microbiome analysis is the temporal quantitative change of microbial diversity between baseline and subsequent study days.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include correlation of metabolite concentration, autophagy and ER stress response markers and change of the microbiome with<br>1. change in SOFA (Sequential Organ Failure Assessment including organ function variables lung, liver, kidney, cardiovascular system, coagulation and central nervous system)-score<br>2. ICU- and hospital length of stay<br>3. 28-day mortality<br>Metabolome- and transcriptome data will be used to construct patient -sepcific metabolic networks, which identify metabolic changes over the individual course of sepsis (early acute and late phase) in order to scrutinize marker that precede these changes (idenfitification of metabotypes).<br>Concomitantly in this translational pilot project, the laboartory and clinical data will be analyzed with the Glucosafe software with the aim to enable an individual prognosis of insulin sensitivity, plasma glucose concentration and metabolic capacity of nutrition therapy and glucose control.