Critical IllnessKRATOSNCT03736005
Skeletal Muscle Wasting and Renal Dysfunction After Critical Illness Trauma - Outcomes Study
An observational study of Critical Illness and Acute Kidney Injury, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Kidney Injury, Muscle Loss
- What is being tested?
- Exposure of significant critical illness
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2018to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to critical care.
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skeletal Muscle Wasting and Renal Dysfunction in Patients After Critical Illness and Major Trauma - Outcomes Study
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.
Read the 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
- Being tested
- Exposure of significant critical illness
- Medical subject headings
- Critical Illness, Acute Kidney Injury, Muscular Atrophy, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure of significant critical illnessOther
Exposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments.
| Study group | Role | What they receive |
|---|---|---|
| General ICU admissions | Non- major trauma ICU admission Exposure to significant period of critical illness Receives: Other: Exposure of significant critical illness | |
| Major Trauma admissions | Exposure to Major Trauma Exposure to significant period of critical illness Receives: Other: Exposure of significant critical illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated Glomerular Filtration Rate (eGFR) between creatinine- and cystatin C-based estimates.
Measured: At 7 days after ICU discharge.
Secondary outcomes (13)
Rectus Femoris muscle wasting
Change in cross sectional area of Rectus Femoris assessed via ultrasound
Measured: 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.
Diagnosis of a negative Nitrogen Balance
Serum and urinary urea measurements aggregated as net nitrogen balance.
Measured: From ICU admission (day 1 to 10) and 7 days after ICU discharge.
Respiratory muscle wasting
Change in cross sectional area of intercostal muscle, change in diaphragm thickness
Measured: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Loss of muscle quality
Change in Rectus femoris muscle echogenecity
Measured: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Loss of functional capacity
Change in Functional Independence Measure
Measured: 7 days and 6 months after ICU discharge.
Diagnosis of Anxiety of Depression
Change in Hospital Anxiety and Depression Scale
Measured: 7 days and 6 months after ICU discharge.
Diagnosis of Sarcopaenia
Assessed using bioelectrical impedance analysis, change in cross sectional area of abdominal skeletal muscle,
Measured: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Diagnosis of Intensive care unit acquired weakness
Assessed using MRC Sum score
Measured: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Diagnosis of Intensive care unit acquired weakness
Assessed using hand grip strength.
Measured: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Change in quality of life
Change in Euroqol 5d 5L (European quality of life group, quality of life instrument version 5D5L)
Measured: pre-admission baseline then 7 days and 6 months after ICU discharge.
Change in walking capacity
Change in Six minute walk test
Measured: 7 days and 6 months after ICU discharge.
Diagnosis of chronic kidney disease
Diagnosis using creatinine clearance, iohexol and serum creatinine derived eGFR
Measured: 6 months after ICU discharge
Diagnosis of non-recovery of eGFR to baseline
Diagnosis using creatinine clearance, iohexol and serum creatinine derived eGFR
Measured: From ICU admission (day 3 to 10) and 7 days after ICU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start19 Dec 2018
- Primary completion1 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736005
- Sponsor's protocol ID
- KRATOSProtocolv1.2
- Acronym
- KRATOS
- Status last verified
- Sep 2022
- First submitted
- 28 Aug 2018
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28614196Haines 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.
PubMed 37256861
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Wasting and Renal Dysfunction in Patients After Critical Illness and Major Trauma - Outcomes Study
- ClinicalTrials.gov ID
- NCT03736005
- Acronym / sponsor ID
- KRATOS / KRATOSProtocolv1.2
- Conditions
- Critical Illness, Acute Kidney Injury, Muscle Loss, Major Trauma, Quality of Life, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General ICU admissions | – | Other: Exposure of significant critical illnessNon- major trauma ICU admission Exposure to significant period of critical illness |
| Major Trauma admissions | – | Other: Exposure of significant critical illnessExposure to Major Trauma Exposure to significant period of critical illness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to critical care.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure of significant critical illnessExposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments. | Other | General ICU admissions, Major Trauma admissions |
Primary outcome
Change in estimated Glomerular Filtration Rate (eGFR) between creatinine- and cystatin C-based estimates.
Time frame: At 7 days after ICU discharge.
13 secondary outcomes
Rectus Femoris muscle wasting
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.
Diagnosis of a negative Nitrogen Balance
Time frame: From ICU admission (day 1 to 10) and 7 days after ICU discharge.
Respiratory muscle wasting
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Loss of muscle quality
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Loss of functional capacity
Time frame: 7 days and 6 months after ICU discharge.
Diagnosis of Anxiety of Depression
Time frame: 7 days and 6 months after ICU discharge.
Diagnosis of Sarcopaenia
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Diagnosis of Intensive care unit acquired weakness
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Diagnosis of Intensive care unit acquired weakness
Time frame: From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.
Change in quality of life
Time frame: pre-admission baseline then 7 days and 6 months after ICU discharge.
Change in walking capacity
Time frame: 7 days and 6 months after ICU discharge.
Diagnosis of chronic kidney disease
Time frame: 6 months after ICU discharge
Diagnosis of non-recovery of eGFR to baseline
Time frame: From ICU admission (day 3 to 10) and 7 days after ICU discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 28614196Ravn 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.
- Derived from this study: PubMed 37256861Haines 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Acute Kidney Injury, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated Glomerular Filtration Rate (eGFR) between creatinine- and cystatin C-based estimates. (time frame: At 7 days after ICU discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736005, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.