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

Quality of Life Clinical Trial

— KRATOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736005
• Other study ID #: KRATOSProtocolv1.2
• Status: Completed
• Start date: December 19, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: September 2022
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Diseases
• Critical Illness
• Kidney Diseases
• Major Trauma
• Muscle Loss
• Muscular Atrophy
• Quality of Life
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Wounds and Injuries

Intervention

Other:
• Exposure of significant critical illness
Exposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments.

Locations

Country	Name	City	State
United Kingdom	Royal London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Ravn B, Prowle JR, Mårtensson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in estimated Glomerular Filtration Rate (eGFR) between creatinine- and cystatin C-based estimates.		At 7 days after ICU discharge.
Secondary	Rectus Femoris muscle wasting	Change in cross sectional area of Rectus Femoris assessed via ultrasound	From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge. Time period up to and including 18 months from recruitment.
Secondary	Diagnosis of a negative Nitrogen Balance	Serum and urinary urea measurements aggregated as net nitrogen balance.	From ICU admission (day 1 to 10) and 7 days after ICU discharge.
Secondary	Respiratory muscle wasting	Change in cross sectional area of intercostal muscle, change in diaphragm thickness	From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Secondary	Loss of muscle quality	Change in Rectus femoris muscle echogenecity	From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Secondary	Loss of functional capacity	Change in Functional Independence Measure	7 days and 6 months after ICU discharge.
Secondary	Diagnosis of Anxiety of Depression	Change in Hospital Anxiety and Depression Scale	7 days and 6 months after ICU discharge.
Secondary	Diagnosis of Sarcopaenia	Assessed using bioelectrical impedance analysis, change in cross sectional area of abdominal skeletal muscle,	From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Secondary	Diagnosis of Intensive care unit acquired weakness	Assessed using MRC Sum score	From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Secondary	Diagnosis of Intensive care unit acquired weakness	Assessed using hand grip strength.	From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Secondary	Change in quality of life	Change in Euroqol 5d 5L (European quality of life group, quality of life instrument version 5D5L)	pre-admission baseline then 7 days and 6 months after ICU discharge.
Secondary	Change in walking capacity	Change in Six minute walk test	7 days and 6 months after ICU discharge.
Secondary	Diagnosis of chronic kidney disease	Diagnosis using creatinine clearance, iohexol and serum creatinine derived eGFR	6 months after ICU discharge
Secondary	Diagnosis of non-recovery of eGFR to baseline	Diagnosis using creatinine clearance, iohexol and serum creatinine derived eGFR	From ICU admission (day 3 to 10) and 7 days after ICU discharge.