Critical Illness Clinical Trial
Official title:
Pilot Observation of the Impact of Human Blood Serum From Critically Ill Patients With or Without Critical-illness-polyneuropathy on Intramural Neuronal Networks of Human Colon Samples
NCT number | NCT02706314 |
Other study ID # | A 2016-0016 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | April 16, 2019 |
Verified date | April 2019 |
Source | University of Rostock |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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. 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. 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)
Status | Completed |
Enrollment | 61 |
Est. completion date | April 16, 2019 |
Est. primary completion date | April 16, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Diagnosis of pre-existing neuromuscular diseases other than CIP - High-dose glucocorticosteroid therapy (> 300 mg Hydrocortisone/die) - Age < 18 |
Country | Name | City | State |
---|---|---|---|
Germany | Intensive Care Unit PIT 1 and 2, University hospital Rostock | Rostock |
Lead Sponsor | Collaborator |
---|---|
University of Rostock |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Incidence of CIP assessed by standardized nerve conduction study | CIP defined as a reduction in the amplitude of compound muscle action potentials and sensory nerve action potentials | Day 10 | |
Secondary | Incidence of CIP assessed by standardized neurological examination | CIP defined as decreased or absent tendon reflexes and/or muscular paresis | Day 10 | |
Secondary | Incidence of peripheral nerve abnormalities assessed by neuromyosonography | Defined as increased nerve cross sectional areas in mm² | Day 10 | |
Secondary | Incidence of abnormalities of muscle echogenicity assesed by neuromyosonography | Abnormal muscle echogenicity defined as mild, moderate or massive increased echogenicity in comparison to bone echogenicity | Day 10 | |
Secondary | Time of respirator-therapy | Day 100 | ||
Secondary | Length of ICU stay | Day 100 | ||
Secondary | The number of participants with death | Day 100 |
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