Impact of Human Blood Serum From Critically Ill Patients on Human Colon Neuronal Networks.

NCT02706314 | Completed

• 1 other identifier: A 2016-0016
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Critical illness in the ICU setting has high medical and socioeconomic importance. Critically ill patients frequently develop severe neurologic impairment during their course of disease, typically presenting as critical-illness-polyneuropathy (CIP), which is associated with an increased mortality rate. To date neither strategies are available to predict nor to specifically treat CIP. Diagnostic tests to determine CIP during the course of critical illness are available through nerve conduction studies. Further research is needed to find diagnostic tools to identify patients who are on high risk to develop CIP, which could encourage the evolution of new therapeutic strategies for CIP patients. The aims of the study are:

1. 1.An early detection of changes in intramural neuronal networks of human colon samples induced by human blood serum from critically ill patients in order to predict the development of CIP
2. 2.The comparison of different diagnostic tests to diagnose and monitor CIP during the course of critical illness (neurologic examination versus nerve conduction study versus neuromyosonography)

Conditions

Critical Illness; Multiple Organ Failure; Polyneuropathy; Myopathy

Outcome Measures

Primary Outcomes (2)

• Changes in the frequency and the amplitude of spontaneous contractions of colonic smooth muscle preparations induced by incubation with serum from critically ill patients with CIP, without CIP and healthy controls

  The parameters will be measured in colonic smooth muscle preparations before and after three hours of incubation with serum from healthy controls as well as critically ill patients with or without CIP. The observed changes in the respective parameter over the three-hour period will be estimated in each tested preparation as measured by absolute values of frequency (contractions per minute) and force (millinewton).

  Baseline and 3 Hours

• Changes in the amplitude, the integrated force and the time to first and last peak of contractions evoked by electric field stimulation in colonic smooth muscle preparations incubated with the above mentioned sera

  Applying the same time protocol as described above for point 1, except for the use of electric field stimulation as an exogenous trigger of contractions, changes in the respective parameter over the three-hour period will be estimated in each tested preparation as measured by absolute values of force (millinewton), integrated force (millinewton\*second) and time (seconds).

  Baseline and 3 Hours

Secondary Outcomes (7)

• Incidence of CIP assessed by standardized nerve conduction study

  Day 10

• Incidence of CIP assessed by standardized neurological examination

  Day 10

• Incidence of peripheral nerve abnormalities assessed by neuromyosonography

  Day 10

• Incidence of abnormalities of muscle echogenicity assesed by neuromyosonography

  Day 10

• Time of respirator-therapy

  Day 100

Study Arms (3)

Critically ill patients with CIP

Critically ill patients with a Sequential Organ Failure Assessment (SOFA)-Score \>7 with CIP

Critically ill patients without CIP

Critically ill patients with a Sequential Organ Failure Assessment (SOFA)-Score \>7 without CIP

Healthy volunteers

Healthy volunteers with neither critical illness nor CIP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with critical illness and fulfilling the inclusion criteria should be screened for the study on two surgical ICUs at the university hospital of Rostock, Germany.

You may qualify if:

• Patients with critical illness, defined as a SOFA-Score ≥ 8 on 3 consecutive days within the first 5 days of ICU stay
• Informed consent by patient or legal proxy

You may not qualify if:

• Diagnosis of pre-existing neuromuscular diseases other than CIP
• High-dose glucocorticosteroid therapy (\> 300 mg Hydrocortisone/die)
• Age \< 18

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

Intensive Care Unit PIT 1 and 2, University hospital Rostock

Rostock, 18055, Germany

Location

Related Publications (1)

• Klawitter F, Laukien F, Fischer DC, Rahn A, Porath K, Danckert L, Bajorat R, Walter U, Patejdl R, Ehler J. Longitudinal Assessment of Blood-Based Inflammatory, Neuromuscular, and Neurovascular Biomarker Profiles in Intensive Care Unit-Acquired Weakness: A Prospective Single-Center Cohort Study. Neurocrit Care. 2025 Feb;42(1):118-130. doi: 10.1007/s12028-024-02050-x. Epub 2024 Jul 9.

  PMID: 38982001 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum probes will be stored at -80°C.

MeSH Terms

Conditions

Critical Illness; Multiple Organ Failure; Polyneuropathies; Muscular Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Johannes Ehler

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 11, 2016
• Study Start: March 1, 2016
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)