Critical Illness PolyneuropathyNCT02763709
Evaluation of Pediatric Critical Illness Neuropathy/Myopathy in Pediatric Intensive Care Unit
An observational study of Critical Illness Polyneuropathy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Intensive Care Unit Acquired Weakness(ICUAW) encompasses a spectrum of disorders characterized by generalized weakness developing after the onset of critical illness. Pediatric data on the incidence of ICUAW is restricted to isolated case reports and case series of no more than five children. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Critical Illness Polyneuropathy
- How many people
- 97 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children admitted in Pediatric Intensive Care Unit for more than 24 hours with a Pediatric Risk of Mortality (PRISM) score III > 20
Who may be able to join
- Children admitted in Pediatric Intensive Care Unit for more than 24 hours
- Pediatric Risk of Mortality (PRISM) score III > 20
Who cannot join
- Previous (Eg: Diabetes Mellitus, Systemic Lupus Erythematosus, Dermatomyositis, Spinal Muscular Atrophy) or current neuromuscular disorder (e.g Guillian Barre Syndrome, snake bite, myositis)
- Use of drugs causing neuromuscular blockade
- Bilateral Lower limb disorders precluding Nerve Conduction Study or ElectroMyoGraphy (Gross edema, fractures, amputation, plaster casts, open wounds, infections)
- Children with abnormal electrophysiological studies at baseline examination will be excluded
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, Chandigarh, 160012
Naveen Sankhyan, MD DM, drnsankhyan@yahoo.co.in
Pratibha Singhi, MD, doctorpratibhasinghi@gmail.com
About this study
Intensive Care Unit Acquired Weakness(ICUAW) encompasses a spectrum of disorders characterized by generalized weakness developing after the onset of critical illness. Pediatric data on the incidence of ICUAW is restricted to isolated case reports and case series of no more than five children. Critical illness polyneuropathy is characterized by reduction in compound motor action potential or sensory nerve action potential or both with preserved conduction velocity on electrophysiological studies. These findings can occur very early prior to the onset of clinical features. Given the dearth of data in children on the subject, this study has been planned to evaluate the incidence of critical illness associated polyneuropathy /myopathy in severely sick children admitted.
Read the detailed description
Materials and Methods
Study Setting: Pediatric Intensive Care Unit, Advanced Pediatric Centre, Postgraduate Institute of Medical Educational Research
Study Period: Jan 2016 to Dec 2016
Study design: Prospective Cohort Study
Study Population: Children of 2 years to 12 years of age
Study flow
All consecutive patients between the age group 2 years to 12 years admitted in Pediatric Intensive Care Unit (ICU) in Advanced pediatric Centre with PRISM score of more than 20 will screened for inclusion in the study.Those found eligible would be included after an informed consent. Baseline clinical and demographic profile will be recorded on a proforma.
Entry Examination
Clinical Evaluation
It would include history and examination. A clinical evaluation will be performed at the time of patient recruitment and then daily till discharge from ICU. It would also include assessment of the Glasgow Coma Scale, the Sequential Organ System Failure score (SOFA) and tendon reflexes. The muscle strength of the main muscle groups will be graded using the Medical Research Council (MRC) scale in cooperative children.
- Upper Extremity: Wrist Extension, Elbow Flexion, Shoulder Abduction
- Lower Extremity: Ankle Dorsiflexion, Knee Extension, Hip Flexion
Scoring \& Interpretation:
- Maximum Score: 60 (4 Limbs, Maximum of 15 Points Per Limb) = Normal
- Minimum Score: 0 = Quadriplegia
Severity of multi organ failure will be assessed by mean SOFA scores during ICU stay, highest SOFA scores and sum of 28-day total SOFA scores in every patient.
The total dose and duration of drug therapy like steroids, muscle relaxants, sedatives and inotropes will also be entered. Laboratory parameters like serum creatine kinase, albumin, total protein, serum electrolytes and plasma blood glucose will also quantified.
Electrophysiological Evaluation
Twenty fours after admission, entry examination in the form of complete nerve conduction study from 4 motor nerves (median, ulnar, tibial and common peroneal nerve) and 2 sensory nerves (median and sural nerve) will be performed. These will consist of Compound Motor Action Potential(CMAP) measurement from motor nerves and Sensory Nerve Action Potential (SNAP) assessment from sensory nerves. Before the electrophysiological tests, heat packs will be applied to the skin if its temperature is below 33°C.
Serial Examination
Following the detailed entry evaluation, daily simplified electrophysiological tests in the form of conduction velocity and amplitude of the sural SNAP and common peroneal CMAP in one leg using surface electrode stimulation and recording electrodes will be assessed. To minimize artifacts, the same electrode site will be marked and similar size electrode will be used for each patient on a daily basis. A 25% decrease from baseline SNAP and CMAP measured at ICU admission will be taken as the minimum consistently detectable reduction.If SNAP or CMAP decreases by more than 25% on two consecutive days, a complete electrophysiological test will be performed. Complete electrophysiological testing includes nerve conduction study and electromyography.Electromyography will be recorded using a coaxial needle electrode in the tibialis anterior and first dorsal interossei.If the complete electrophysiological test is consistent with critical illness weakness, complete weekly tests will replace daily tests until ICU discharge.
- Conditions
- Critical Illness Polyneuropathy
- Medical subject headings
- Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Children admitted in Pediatric ICU for more than 24 hours with Pediatric Risk of Mortality (PRISM) score III > 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pediatric critical illness polyneuropathy/myopathy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Illness PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ananthanarayanan, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Naveen Sankhyan, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhPratibha Singhi, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763709
- Sponsor's protocol ID
- PEDCIMP2016
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kasinathan A, Sharawat IK, Singhi P, Jayashree M, Sahu JK, Sankhyan N. Intensive Care Unit-Acquired Weakness in Children: A Prospective Observational Study Using Simplified Serial Electrophysiological Testing (PEDCIMP Study). Neurocrit Care. 2021 Jun;34(3):927-934. doi: 10.1007/s12028-020-01123-x. Epub 2020 Oct 7.
PubMed 33025545
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pediatric Critical Illness Neuropathy/Myopathy in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02763709
- Acronym / sponsor ID
- PEDCIMP2016
- Conditions
- Critical Illness Polyneuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intensive Care Unit Acquired Weakness(ICUAW) encompasses a spectrum of disorders characterized by generalized weakness developing after the onset of critical illness. Pediatric data on the incidence of ICUAW is restricted to isolated case reports and case series of no more than five children. Critical illness polyneuropathy is characterized by reduction in compound motor action potential or sensory nerve action potential or both with preserved conduction velocity on electrophysiological studies. These findings can occur very early prior to the onset of clinical features. Given the dearth of data in children on the subject, this study has been planned to evaluate the incidence of critical illness associated polyneuropathy /myopathy in severely sick children admitted.
Detailed description
Materials and Methods
Study Setting: Pediatric Intensive Care Unit, Advanced Pediatric Centre, Postgraduate Institute of Medical Educational Research
Study Period: Jan 2016 to Dec 2016
Study design: Prospective Cohort Study
Study Population: Children of 2 years to 12 years of age
Study flow
All consecutive patients between the age group 2 years to 12 years admitted in Pediatric Intensive Care Unit (ICU) in Advanced pediatric Centre with PRISM score of more than 20 will screened for inclusion in the study.Those found eligible would be included after an informed consent. Baseline clinical and demographic profile will be recorded on a proforma.
Entry Examination
Clinical Evaluation
It would include history and examination. A clinical evaluation will be performed at the time of patient recruitment and then daily till discharge from ICU. It would also include assessment of the Glasgow Coma Scale, the Sequential Organ System Failure score (SOFA) and tendon reflexes. The muscle strength of the main muscle groups will be graded using the Medical Research Council (MRC) scale in cooperative children.
- Upper Extremity: Wrist Extension, Elbow Flexion, Shoulder Abduction
- Lower Extremity: Ankle Dorsiflexion, Knee Extension, Hip Flexion
Scoring \& Interpretation:
- Maximum Score: 60 (4 Limbs, Maximum of 15 Points Per Limb) = Normal
- Minimum Score: 0 = Quadriplegia
Severity of multi organ failure will be assessed by mean SOFA scores during ICU stay, highest SOFA scores and sum of 28-day total SOFA scores in every patient.
The total dose and duration of drug therapy like steroids, muscle relaxants, sedatives and inotropes will also be entered. Laboratory parameters like serum creatine kinase, albumin, total protein, serum electrolytes and plasma blood glucose will also quantified.
Electrophysiological Evaluation
Twenty fours after admission, entry examination in the form of complete nerve conduction study from 4 motor nerves (median, ulnar, tibial and common peroneal nerve) and 2 sensory nerves (median and sural nerve) will be performed. These will consist of Compound Motor Action Potential(CMAP) measurement from motor nerves and Sensory Nerve Action Potential (SNAP) assessment from sensory nerves. Before the electrophysiological tests, heat packs will be applied to the skin if its temperature is below 33°C.
Serial Examination
Following the detailed entry evaluation, daily simplified electrophysiological tests in the form of conduction velocity and amplitude of the sural SNAP and common peroneal CMAP in one leg using surface electrode stimulation and recording electrodes will be assessed. To minimize artifacts, the same electrode site will be marked and similar size electrode will be used for each patient on a daily basis. A 25% decrease from baseline SNAP and CMAP measured at ICU admission will be taken as the minimum consistently detectable reduction.If SNAP or CMAP decreases by more than 25% on two consecutive days, a complete electrophysiological test will be performed. Complete electrophysiological testing includes nerve conduction study and electromyography.Electromyography will be recorded using a coaxial needle electrode in the tibialis anterior and first dorsal interossei.If the complete electrophysiological test is consistent with critical illness weakness, complete weekly tests will replace daily tests until ICU discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Children admitted in Pediatric ICU for more than 24 hours with Pediatric Risk of Mortality (PRISM) score III > 20 |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children admitted in Pediatric Intensive Care Unit for more than 24 hours with a Pediatric Risk of Mortality (PRISM) score III > 20
Key inclusion criteria (2 listed)
- Children admitted in Pediatric Intensive Care Unit for more than 24 hours
- Pediatric Risk of Mortality (PRISM) score III > 20
Key exclusion criteria (4 listed)
- Previous (Eg: Diabetes Mellitus, Systemic Lupus Erythematosus, Dermatomyositis, Spinal Muscular Atrophy) or current neuromuscular disorder (e.g Guillian Barre Syndrome, snake bite, myositis)
- Use of drugs causing neuromuscular blockade
- Bilateral Lower limb disorders precluding Nerve Conduction Study or ElectroMyoGraphy (Gross edema, fractures, amputation, plaster casts, open wounds, infections)
- Children with abnormal electrophysiological studies at baseline examination will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Pediatric critical illness polyneuropathy/myopathy
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Derived from this study: PubMed 33025545Kasinathan A, Sharawat IK, Singhi P, Jayashree M, Sahu JK, Sankhyan N. Intensive Care Unit-Acquired Weakness in Children: A Prospective Observational Study Using Simplified Serial Electrophysiological Testing (PEDCIMP Study). Neurocrit Care. 2021 Jun;34(3):927-934. doi: 10.1007/s12028-020-01123-x. Epub 2020 Oct 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Sankhyan, DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
Pratibha Singhi, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness Polyneuropathy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ananthanarayanan K, MD (09814393609, cerebratelife@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pediatric critical illness polyneuropathy/myopathy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.