Royal London Hospital
London, E11BB, United Kingdom
NCT Number: NCT03736005
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.
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Notify Me18 year and older
All sexes
Observational
London, E11BB, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments.
Time frame: At 7 days after ICU discharge.
Time frame: 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.
Change in cross sectional area of Rectus Femoris assessed via ultrasound
Time frame: From ICU admission (day 1 to 10) and 7 days after ICU discharge.
Serum and urinary urea measurements aggregated as net nitrogen balance.
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Change in cross sectional area of intercostal muscle, change in diaphragm thickness
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Change in Rectus femoris muscle echogenecity
Time frame: 7 days and 6 months after ICU discharge.
Change in Functional Independence Measure
Time frame: 7 days and 6 months after ICU discharge.
Change in Hospital Anxiety and Depression Scale
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Assessed using bioelectrical impedance analysis, change in cross sectional area of abdominal skeletal muscle,
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Assessed using MRC Sum score
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Assessed using hand grip strength.
Time frame: pre-admission baseline then 7 days and 6 months after ICU discharge.
Change in Euroqol 5d 5L (European quality of life group, quality of life instrument version 5D5L)
Time frame: 7 days and 6 months after ICU discharge.
Change in Six minute walk test
Time frame: 6 months after ICU discharge
Diagnosis using creatinine clearance, iohexol and serum creatinine derived eGFR
Time frame: From ICU admission (day 3 to 10) and 7 days after ICU discharge.
Diagnosis using creatinine clearance, iohexol and serum creatinine derived eGFR
Queen Mary University of London
Other
Skeletal Muscle Wasting and Renal Dysfunction in Patients After Critical Illness and Major Trauma - Outcomes Study
Acronym: KRATOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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