Pediatric Rhabdomyolysis in the Pediatric Intensive Care Unit: A Retrospective Cohort Study

NCT07851987 | Completed

• 1 other identifier: RHABDO-2026-01
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rhabdomyolysis

Keywords

rhabdomyolysis; acute kidney injury; pediatric intensive care; children; prognostic model; mortality; dialysis; myoglobin; creatininkinase

Outcome Measures

Primary Outcomes (6)

• 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.

  From PICU admission until PICU discharge ( an average of 18 days)

• Mortality

  All-cause mortality during PICU admission.

  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.

  From PICU admission until PICU discharge ( an average of 18 days)

• Duration of invasive mechanical ventilation

  Duration of invasive mechanical ventilation during PICU admission.

  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

  From PICU admission until PICU discharge ( an average of 18 days)

• Requirement for renal replacement therapy

  Requirement for renal replacement therapy during PICU admission

  From PICU admission until PICU discharge ( an average of 18 days)

Secondary Outcomes (8)

• Peak creatine kinase (CK)

  From PICU admission until PICU discharge ( an average of 18 days)

• Peak myoglobin

  From PICU admission until PICU discharge ( an average of 18 days)

• Etiology of rhabdomyolysis

  Baseline (PICU admission)

• Multiple organ involvement

  From PICU admission until PICU discharge ( an average of 18 days)

• Comorbidities

  Baseline (PICU admission)

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• Peak serum creatine kinase (CK) concentration \< 1,000 IU/L.
• Incomplete clinical data preventing retrospective analysis.

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Rhabdomyolysis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: October 1, 2026
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)