Skeletal Muscle Wasting and Renal Dysfunction After Critical Illness Trauma - Outcomes Study

NCT ID: NCT03736005

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2022-01-01

Brief Summary

This study aims to determine changes in kidney function during and after critical illness, comparing conventional creatinine based methods with the gold standard to accurately establish the presence of new or worsened chronic kidney disease. In addition, investigators will assess the confounding effect of muscle wasting on the conventional assessment of kidney function and investigate the information that measures of kidney function may contribute to the assessment of musculoskeletal health after critical illness.

Detailed Description

More people than ever are surviving life-threatening illnesses such as major trauma. However, until now doctors and researchers have focused more on improving short term survival than on the serious, long-term complications experienced by survivors of critical illness. In response, the National Institute for Health and Care Excellence (NICE) and patient-clinician partnerships such as the James Lind Alliance, have now prioritised research into the diagnosis, follow-up and treatment of critical care survivors.

Development of chronic kidney disease and persistent muscle weakness are two commonly encountered complications which significantly impact long-term health and wellbeing after critical illness. Worsening of kidney function strongly predisposes to development of heart disease, premature death or need for long-term dialysis. Similarly, the muscle wasting experienced by almost all survivors of critical illness can result in persistent, life changing limitations to daily living, inability to work and decreased quality of life. Importantly, the human and economic consequences of critical illness may be particularly profound in major trauma victims who are often young and previously healthy. In this project, investigators will aim to simultaneously measure changes in kidney function and muscle mass after critical illness allowing researchers to understand how these processes interact in affecting longer-term patient outcomes.

The investigators will recruit 62 patients, 31 admitted to intensive care after major trauma and 31 admitted for other reasons. Complementary methods will be used to accurately monitor muscle mass and kidney function. Six months after discharge from hospital, patient's ability to manage their daily activities and quality of life will be assessed alongside measurements of muscle mass, strength and kidney function. The study will be performed at the Royal London Hospital, an internationally renowned centre for critical care and trauma research.

Conditions

Critical Illness; Acute Kidney Injury; Muscle Loss; Major Trauma; Quality of Life; Chronic Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

General ICU admissions

Non- major trauma ICU admission Exposure to significant period of critical illness

Exposure of significant critical illness

Intervention Type: OTHER

Exposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments.

Major Trauma admissions

Exposure to Major Trauma Exposure to significant period of critical illness

Exposure of significant critical illness

Intervention Type: OTHER

Exposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments.

Interventions

Exposure of significant critical illness

Exposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Major trauma cohort: Patients ≥18y admitted to ICU and anticipated to be mechanically ventilated for ≥48 hours with a primary admission diagnosis of major trauma.
• Non-trauma cohort: Patients ≥18y admitted to ICU and anticipated to be mechanically ventilated for ≥48 hours without a primary admission diagnosis of major trauma.

Exclusion Criteria

• Death or discharge from hospital considered highly likely by treating physician within 7 days of ICU admission.
• Any of the following conditions: major traumatic brain injury (Abbreviated Injury Scale head injury score ≥ 5), spinal cord injury with paralysis, lower limb amputation, end stage renal disease or disseminated cancer, lack of independence with activities of daily living or non-ambulatory status prior to admission. (Rationale - exclusion of factors where type of injury or comorbid disease will overwhelming determine functional or renal outcomes.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal London Hospital

London, , United Kingdom

Countries

United Kingdom

References

Ravn B, Prowle JR, Martensson J, Martling CR, Bell M. Superiority of Serum Cystatin C Over Creatinine in Prediction of Long-Term Prognosis at Discharge From ICU. Crit Care Med. 2017 Sep;45(9):e932-e940. doi: 10.1097/CCM.0000000000002537.

Reference Type: BACKGROUND

PMID: 28614196 (View on PubMed)

Haines RW, Fowler AJ, Liang K, Pearse RM, Larsson AO, Puthucheary Z, Prowle JR. Comparison of Cystatin C and Creatinine in the Assessment of Measured Kidney Function during Critical Illness. Clin J Am Soc Nephrol. 2023 Aug 1;18(8):997-1005. doi: 10.2215/CJN.0000000000000203. Epub 2023 May 31.

Reference Type: DERIVED

PMID: 37256861 (View on PubMed)

Other Identifiers

KRATOSProtocolv1.2

Identifier Type: -

Identifier Source: org_study_id