Clinical trial NCT03736005: Skeletal Muscle Wasting and Renal Dysfunction After Critical Illness Trauma - Outcomes Study
Official title: Skeletal Muscle Wasting and Renal Dysfunction in Patients After Critical Illness and Major Trauma - Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Acute Kidney Injury
Muscle Loss
Major Trauma
Quality of Life
Chronic Kidney Diseases
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to critical care.

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.

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.)

Primary outcomes:
measure: Change in estimated Glomerular Filtration Rate (eGFR) between creatinine- and cystatin C-based estimates.
timeFrame: At 7 days after ICU discharge.
Secondary outcomes:
measure: Rectus Femoris muscle wasting
timeFrame: 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.
measure: Diagnosis of a negative Nitrogen Balance
timeFrame: From ICU admission (day 1 to 10) and 7 days after ICU discharge.
measure: Respiratory muscle wasting
timeFrame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
measure: Loss of muscle quality
timeFrame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
measure: Loss of functional capacity
timeFrame: 7 days and 6 months after ICU discharge.
measure: Diagnosis of Anxiety of Depression
timeFrame: 7 days and 6 months after ICU discharge.
measure: Diagnosis of Sarcopaenia
timeFrame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
measure: Diagnosis of Intensive care unit acquired weakness
timeFrame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
measure: Diagnosis of Intensive care unit acquired weakness
timeFrame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
measure: Change in quality of life
timeFrame: pre-admission baseline then 7 days and 6 months after ICU discharge.
measure: Change in walking capacity
timeFrame: 7 days and 6 months after ICU discharge.
measure: Diagnosis of chronic kidney disease
timeFrame: 6 months after ICU discharge
measure: Diagnosis of non-recovery of eGFR to baseline
timeFrame: From ICU admission (day 3 to 10) and 7 days after ICU discharge.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
References:
citation: 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.