RhabdomyolysisNCT07851987
Pediatric Rhabdomyolysis in the Pediatric Intensive Care Unit: A Retrospective Cohort Study
An observational study of Rhabdomyolysis, run by Hannover Medical School at 1 site in Germany.
Trial summary
This retrospective observational cohort study aims to evaluate the clinical characteristics, causes, intensive care management, and outcomes of pediatric patients with rhabdomyolysis admitted to the Pediatric Intensive Care Unit (PICU) at Hannover Medical School between 2007 and 2020. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Rhabdomyolysis
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2025to 30 Mar 2026
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consisted of pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) at Hannover Medical School, Germany, between January 1, 2007, and December 31, 2020. Eligible patients were identified retrospectively from routinely collected electronic hospital records. The cohort represents children treated for rhabdomyolysis at a tertiary care university hospital
Who may be able to join
- Pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) at Hannover Medical School, Germany, between January 1, 2007, and December 31, 2020.
- ICD-10 diagnosis codes: M62.2 (non-traumatic muscle necrosis) or T79 (traumatic rhabdomyolysis)
- Peak serum creatine kinase (CK) concentration ≥1,000 IU/L.
- Availability of complete clinical data required for retrospective analysis.
Who cannot join
- Peak serum creatine kinase (CK) concentration < 1,000 IU/L.
- Incomplete clinical data preventing retrospective analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rhabdomyolysis in the Pediatric Intensive Care Unit: Development of a Prognostic Score & Analysis of Clinical Relevance
This retrospective observational cohort study aims to evaluate the clinical characteristics, causes, intensive care management, and outcomes of pediatric patients with rhabdomyolysis admitted to the Pediatric Intensive Care Unit (PICU) at Hannover Medical School between 2007 and 2020. The study uses routinely collected clinical data from medical records without any study-related intervention or additional patient contact.
The primary objective is to identify factors associated with acute kidney injury, mortality, organ failure, and intensive care resource utilization. In addition, the study aims to develop a prognostic score to support early risk stratification of critically ill children with rhabdomyolysis. The findings may improve the understanding of this rare condition and support future clinical decision-making.
Read the detailed description
Rhabdomyolysis is a rare but potentially life-threatening condition in children characterized by skeletal muscle injury and the release of intracellular components into the circulation. Clinical presentation ranges from mild disease to severe complications, including acute kidney injury, multiple organ dysfunction, and death. Current evidence is limited because most published studies are based on small retrospective case series, and prognostic factors for critically ill pediatric patients remain insufficiently characterized.
This is a single-center, retrospective observational cohort study conducted at the Department of Pediatric Cardiology and Intensive Care Medicine, Hannover Medical School, Germany. The study includes pediatric patients treated in the Pediatric Intensive Care Unit (PICU) between January 1, 2007, and December 31, 2020, with a diagnosis of rhabdomyolysis. Clinical, laboratory, and treatment data are extracted from routinely collected electronic medical records. No study-related interventions are performed, and no additional patient contact takes place.
The study aims to characterize the etiology, clinical course, intensive care resource utilization, and outcomes of pediatric rhabdomyolysis in routine clinical practice. Furthermore, routinely collected clinical and laboratory parameters will be evaluated to develop a prognostic model for early risk stratification of acute kidney injury and mortality in critically ill children. The results are expected to improve the understanding of this rare disease and provide evidence to support future clinical management and research.
- Conditions
- Rhabdomyolysis
- Keywords
- rhabdomyolysis, acute kidney injury, pediatric intensive care, children, prognostic model, mortality, dialysis, myoglobin, creatininkinase
- Medical subject headings
- Rhabdomyolysis, Acute Kidney Injury
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 |
|---|---|---|
| Pediatric patients with rhabdomyolysis | Pediatric patients with rhabdomyolysis admitted to the Pediatric Intensive Care Unit (PICU) at Hannover Medical School between January 1, 2007, and December 31, 2020, who fulfilled the predefined eligibility criteria and were included in the final retrospective analysis. Clinical data were obtained from routinely collected medical records. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury (AKI)
Occurrence of acute kidney injury during PICU admission, defined according to the pediatric Risk, Injury, Failure, Loss, End-stage renal disease (pRIFLE) criteria.
Measured: From PICU admission until PICU discharge ( an average of 18 days)
Mortality
All-cause mortality during PICU admission.
Measured: From PICU admission until PICU discharge ( an average of 18 days)
Organ Failure
Occurrence of organ failure during the PICU stay based on predefined clinical and laboratory criteria, including respiratory, renal, hepatic, cardiovascular, and multiple organ failure.
Measured: From PICU admission until PICU discharge ( an average of 18 days)
Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation during PICU admission.
Measured: From initiation of invasive mechanical ventilation until discontinuation (up to PICU discharge, in the median 7 days).
Length of PICU stay
Length of stay in the pediatric intensive care unit
Measured: From PICU admission until PICU discharge ( an average of 18 days)
Requirement for renal replacement therapy
Requirement for renal replacement therapy during PICU admission
Measured: From PICU admission until PICU discharge ( an average of 18 days)
Secondary outcomes (8)
Peak creatine kinase (CK)
Highest serum creatine kinase (CK) concentration recorded on each PICU day and used for longitudinal statistical analyses.
Measured: From PICU admission until PICU discharge ( an average of 18 days)
Peak myoglobin
Highest serum myoglobin concentration recorded on each PICU day and used for longitudinal statistical analyses
Measured: From PICU admission until PICU discharge ( an average of 18 days)
Etiology of rhabdomyolysis
Distribution of the underlying causes of rhabdomyolysis in the study population.
Measured: Baseline (PICU admission)
Multiple organ involvement
Presence of multiple organ involvement during PICU stay.
Measured: From PICU admission until PICU discharge ( an average of 18 days)
Comorbidities
Pre-existing medical conditions associated with pediatric rhabdomyolysis.
Measured: Baseline (PICU admission)
Systemic inflammatory response syndrome (SIRS) or sepsis
Occurrence of systemic inflammatory response syndrome (SIRS) or sepsis according to the International Pediatric Sepsis Consensus Conference criteria.
Measured: From PICU admission until PICU discharge ( an average of 18 days)
Pediatric Index of Mortality II (PIM II)
Disease severity at PICU admission assessed using the Pediatric Index of Mortality II (PIM II). PIM II estimates the predicted probability of mortality (%) in pediatric intensive care patients. Higher percentages indicate a higher predicted risk of death and greater disease severity.
Measured: Baseline (PICU admission)
Pediatric Risk of Mortality III (PRISM III)
Disease severity at PICU admission assessed using the Pediatric Risk of Mortality III (PRISM III) score. The PRISM III score ranges from 0 to 74 points, with higher scores indicating greater disease severity and a higher predicted risk of mortality.
Measured: Baseline (PICU admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyolysisStudies 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
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851987
- Sponsor's protocol ID
- RHABDO-2026-01
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this retrospective observational study uses pseudonymized patient data collected during routine clinical care. Data sharing is restricted by institutional policies, ethical requirements, and applicable data protection regulations (including the General Data Protection Regulation \[GDPR\]).
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhabdomyolysis in the Pediatric Intensive Care Unit: Development of a Prognostic Score & Analysis of Clinical Relevance
- ClinicalTrials.gov ID
- NCT07851987
- Acronym / sponsor ID
- RHABDO-2026-01
- Conditions
- Rhabdomyolysis
- Keywords
- rhabdomyolysis, acute kidney injury, pediatric intensive care, children, prognostic model, mortality, dialysis, myoglobin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 1 Oct 2026 (actual)
- 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.
This retrospective observational cohort study aims to evaluate the clinical characteristics, causes, intensive care management, and outcomes of pediatric patients with rhabdomyolysis admitted to the Pediatric Intensive Care Unit (PICU) at Hannover Medical School between 2007 and 2020. The study uses routinely collected clinical data from medical records without any study-related intervention or additional patient contact.
The primary objective is to identify factors associated with acute kidney injury, mortality, organ failure, and intensive care resource utilization. In addition, the study aims to develop a prognostic score to support early risk stratification of critically ill children with rhabdomyolysis. The findings may improve the understanding of this rare condition and support future clinical decision-making.
Detailed description
Rhabdomyolysis is a rare but potentially life-threatening condition in children characterized by skeletal muscle injury and the release of intracellular components into the circulation. Clinical presentation ranges from mild disease to severe complications, including acute kidney injury, multiple organ dysfunction, and death. Current evidence is limited because most published studies are based on small retrospective case series, and prognostic factors for critically ill pediatric patients remain insufficiently characterized.
This is a single-center, retrospective observational cohort study conducted at the Department of Pediatric Cardiology and Intensive Care Medicine, Hannover Medical School, Germany. The study includes pediatric patients treated in the Pediatric Intensive Care Unit (PICU) between January 1, 2007, and December 31, 2020, with a diagnosis of rhabdomyolysis. Clinical, laboratory, and treatment data are extracted from routinely collected electronic medical records. No study-related interventions are performed, and no additional patient contact takes place.
The study aims to characterize the etiology, clinical course, intensive care resource utilization, and outcomes of pediatric rhabdomyolysis in routine clinical practice. Furthermore, routinely collected clinical and laboratory parameters will be evaluated to develop a prognostic model for early risk stratification of acute kidney injury and mortality in critically ill children. The results are expected to improve the understanding of this rare disease and provide evidence to support future clinical management and research.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with rhabdomyolysis | – | –Pediatric patients with rhabdomyolysis admitted to the Pediatric Intensive Care Unit (PICU) at Hannover Medical School between January 1, 2007, and December 31, 2020, who fulfilled the predefined eligibility criteria and were included in the final retrospective analysis. Clinical data were obtained from routinely collected medical records. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consisted of pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) at Hannover Medical School, Germany, between January 1, 2007, and December 31, 2020. Eligible patients were identified retrospectively from routinely collected electronic hospital records. The cohort represents children treated for rhabdomyolysis at a tertiary care university hospital
Key inclusion criteria (4 listed)
- Pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) at Hannover Medical School, Germany, between January 1, 2007, and December 31, 2020.
- ICD-10 diagnosis codes: M62.2 (non-traumatic muscle necrosis) or T79 (traumatic rhabdomyolysis)
- Peak serum creatine kinase (CK) concentration ≥1,000 IU/L.
- Availability of complete clinical data required for retrospective analysis.
Key exclusion criteria (2 listed)
- Peak serum creatine kinase (CK) concentration < 1,000 IU/L.
- Incomplete clinical data preventing retrospective analysis.
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
Acute Kidney Injury (AKI)
Time frame: From PICU admission until PICU discharge ( an average of 18 days)
Occurrence of acute kidney injury during PICU admission, defined according to the pediatric Risk, Injury, Failure, Loss, End-stage renal disease (pRIFLE) criteria.
Mortality
Time frame: From PICU admission until PICU discharge ( an average of 18 days)
All-cause mortality during PICU admission.
Organ Failure
Time frame: From PICU admission until PICU discharge ( an average of 18 days)
Occurrence of organ failure during the PICU stay based on predefined clinical and laboratory criteria, including respiratory, renal, hepatic, cardiovascular, and multiple organ failure.
Duration of invasive mechanical ventilation
Time frame: From initiation of invasive mechanical ventilation until discontinuation (up to PICU discharge, in the median 7 days).
Duration of invasive mechanical ventilation during PICU admission.
Length of PICU stay
Time frame: From PICU admission until PICU discharge ( an average of 18 days)
Length of stay in the pediatric intensive care unit
Requirement for renal replacement therapy
Time frame: From PICU admission until PICU discharge ( an average of 18 days)
Requirement for renal replacement therapy during PICU admission
8 secondary outcomes
Peak creatine kinase (CK)
Time frame: From PICU admission until PICU discharge ( an average of 18 days)
Peak myoglobin
Time frame: From PICU admission until PICU discharge ( an average of 18 days)
Etiology of rhabdomyolysis
Time frame: Baseline (PICU admission)
Multiple organ involvement
Time frame: From PICU admission until PICU discharge ( an average of 18 days)
Comorbidities
Time frame: Baseline (PICU admission)
Systemic inflammatory response syndrome (SIRS) or sepsis
Time frame: From PICU admission until PICU discharge ( an average of 18 days)
Pediatric Index of Mortality II (PIM II)
Time frame: Baseline (PICU admission)
Pediatric Risk of Mortality III (PRISM III)
Time frame: Baseline (PICU admission)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this retrospective observational study uses pseudonymized patient data collected during routine clinical care. Data sharing is restricted by institutional policies, ethical requirements, and applicable data protection regulations (including the General Data Protection Regulation [GDPR]).
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rhabdomyolysis, run by Hannover Medical School at 1 site in Germany.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 2026. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (AKI) (time frame: From PICU admission until PICU discharge ( an average of 18 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.