COVIDNCT04445259
Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
An observational study of COVID and Acute Kidney Injury, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Acute Kidney Injury, Critical Illness
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2020to 31 Dec 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
- Adult, Older adult
Study population: Adult critically ill patients with confirmed diagnosis of COVID-19
Who may be able to join
- Adults (aged ≥18 years)
- Confirmed diagnosis of COVID-19
- Hospitalized in the ICU for illness related to COVID-19
- Any of the following:
- Current in-patient in ICU
- Previous in-patient in ICU and died in ICU or hospital
- Previous in-patient in ICU and discharged from ICU alive
Who cannot join
- Younger than 18 years old
- On chronic dialysis within the last year or on dialysis at ICU admission
- Functioning kidney transplant
- No creatinine within 48 hours of ICU admission
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas' Hospital
London, SE1 7EH
Marlies Ostermann, MD, PhD, 020 71883038, Marlies.Ostermann@gstt.nhs.uk
About this study
The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.
Read the detailed description
Since the outbreak of coronavirus disease 2019 (COVID-19) began in December 2019 in China, over 1 million people have been infected and over 55,000 have died worldwide, and these numbers continue to rise. Combating this pandemic requires a multidisciplinary approach from the medical research community, including translational studies to understand the pathogenesis of disease, randomized controlled trials of novel and re-purposed pharmacotherapies, and rigorously conducted epidemiologic studies that include granular patient-level data.
Current knowledge of the clinical features and outcomes of COVID-19 is mostly limited to studies from China and Italy. In one of the larger such studies, which consisted of 1099 patients hospitalized in mainland China, only 173 (16%) were classified as having severe disease, and only 15 (1.4%) died. The study was therefore inadequately powered to determine independent risk factors for death. A larger study consisting of 72,314 patients was recently published by the Chinese Center for Disease Control and Prevention. This nationwide registry study identified several important findings, including the striking monotonic relationship between older age and greater risk of death. Important limitations of the study, however, were lack of granular patient-level data and relatively few patients (<5% of the cohort) who were critically ill. Among critically ill patients with COVID-19, acute mortality rates have been reported to be as high as 49-62%, underscoring the importance of studying this patient population. Data from the United Kingdom (UK) suggest that >50% of critically ill patients have a degree of acute kidney injury (AKI) and >20% need renal replacement therapy (RRT). Mortality is particularly high in those who are mechanically ventilated and need RRT (>75%).
Detailed information about the risk of AKI, contributing factors and reasons for high mortality in critically ill COVID-19 patients is lacking. To meet this urgent need, the investigators plan to collect clinical data from >250 critically ill patients with COVID-19 admitted to the intensive care unit (ICU) at Guy's \& St Thomas' Hospital. The investigators will collaborate with Dr Gupta and Prof Leaf from Harvard Medical School, Boston (US) who are leading a similar study across >50 sites in the United States.
The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.
- Conditions
- COVID, Acute Kidney Injury, Critical Illness
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Patients with COVID-19 | We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any stage of acute kidney injury
As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria
Measured: 14 days
Secondary outcomes (8)
Mortality
Mortality
Measured: 14-day, hospital, and intensive care unit (ICU) mortality
Renal recovery
Defined by return of creatinine to < 1.5 times of baseline
Measured: 14 days
Percentage of patients who receive renal replacement therapy
Percentage
Measured: 14 days
Percentage of participants who are dialysis dependent
Percentage of participants who are dialysis dependent
Measured: Through study completion, an average of 90 days
Free-days of vasoactive medications and mechanical ventilation
Days without vasoactive medications and mechanical ventilation
Measured: Day 30
Length of intensive care unit and hospital stay
Length of intensive care unit and hospital stay
Measured: Through study completion, an average of 90 days
Number of participants with consequences following AKI
Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumonia
Measured: Through study completion, an average of 90 days
Time from illness onset to need for mechanical ventilator support
Time from illness onset to need for mechanical ventilator support
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start20 Jun 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 COVIDStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Nuttha Lumlertgul, MD, PhD, Principal investigator, Guy's & St Thomas' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445259
- Sponsor's protocol ID
- 283672
- Status last verified
- Aug 2021
- First submitted
- 27 May 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lumlertgul N, Baker E, Pearson E, Dalrymple KV, Pan J, Jheeta A, Weerapolchai K, Wang Y, Leach R, Barrett NA, Ostermann M. Changing epidemiology of acute kidney injury in critically ill patients with COVID-19: a prospective cohort. Ann Intensive Care. 2022 Dec 28;12(1):118. doi: 10.1186/s13613-022-01094-6.
PubMed 36575315Lumlertgul N, Pirondini L, Cooney E, Kok W, Gregson J, Camporota L, Lane K, Leach R, Ostermann M. Acute kidney injury prevalence, progression and long-term outcomes in critically ill patients with COVID-19: a cohort study. Ann Intensive Care. 2021 Aug 6;11(1):123. doi: 10.1186/s13613-021-00914-5.
PubMed 34357478
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04445259
- Acronym / sponsor ID
- 283672
- Conditions
- COVID, Acute Kidney Injury, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Jun 2020 (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.
The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.
Detailed description
Since the outbreak of coronavirus disease 2019 (COVID-19) began in December 2019 in China, over 1 million people have been infected and over 55,000 have died worldwide, and these numbers continue to rise. Combating this pandemic requires a multidisciplinary approach from the medical research community, including translational studies to understand the pathogenesis of disease, randomized controlled trials of novel and re-purposed pharmacotherapies, and rigorously conducted epidemiologic studies that include granular patient-level data.
Current knowledge of the clinical features and outcomes of COVID-19 is mostly limited to studies from China and Italy. In one of the larger such studies, which consisted of 1099 patients hospitalized in mainland China, only 173 (16%) were classified as having severe disease, and only 15 (1.4%) died. The study was therefore inadequately powered to determine independent risk factors for death. A larger study consisting of 72,314 patients was recently published by the Chinese Center for Disease Control and Prevention. This nationwide registry study identified several important findings, including the striking monotonic relationship between older age and greater risk of death. Important limitations of the study, however, were lack of granular patient-level data and relatively few patients (<5% of the cohort) who were critically ill. Among critically ill patients with COVID-19, acute mortality rates have been reported to be as high as 49-62%, underscoring the importance of studying this patient population. Data from the United Kingdom (UK) suggest that >50% of critically ill patients have a degree of acute kidney injury (AKI) and >20% need renal replacement therapy (RRT). Mortality is particularly high in those who are mechanically ventilated and need RRT (>75%).
Detailed information about the risk of AKI, contributing factors and reasons for high mortality in critically ill COVID-19 patients is lacking. To meet this urgent need, the investigators plan to collect clinical data from >250 critically ill patients with COVID-19 admitted to the intensive care unit (ICU) at Guy's \& St Thomas' Hospital. The investigators will collaborate with Dr Gupta and Prof Leaf from Harvard Medical School, Boston (US) who are leading a similar study across >50 sites in the United States.
The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Patients with COVID-19 | – | –We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients with confirmed diagnosis of COVID-19
Key inclusion criteria (7 listed)
- Adults (aged ≥18 years)
- Confirmed diagnosis of COVID-19
- Hospitalized in the ICU for illness related to COVID-19
- Any of the following:
Key exclusion criteria (4 listed)
- Younger than 18 years old
- On chronic dialysis within the last year or on dialysis at ICU admission
- Functioning kidney transplant
- No creatinine within 48 hours of ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of any stage of acute kidney injury
Time frame: 14 days
As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria
8 secondary outcomes
Mortality
Time frame: 14-day, hospital, and intensive care unit (ICU) mortality
Renal recovery
Time frame: 14 days
Percentage of patients who receive renal replacement therapy
Time frame: 14 days
Percentage of participants who are dialysis dependent
Time frame: Through study completion, an average of 90 days
Free-days of vasoactive medications and mechanical ventilation
Time frame: Day 30
Length of intensive care unit and hospital stay
Time frame: Through study completion, an average of 90 days
Number of participants with consequences following AKI
Time frame: Through study completion, an average of 90 days
Time from illness onset to need for mechanical ventilator support
Time frame: Through study completion, an average of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 36575315Lumlertgul N, Baker E, Pearson E, Dalrymple KV, Pan J, Jheeta A, Weerapolchai K, Wang Y, Leach R, Barrett NA, Ostermann M. Changing epidemiology of acute kidney injury in critically ill patients with COVID-19: a prospective cohort. Ann Intensive Care. 2022 Dec 28;12(1):118. doi: 10.1186/s13613-022-01094-6.
- Derived from this study: PubMed 34357478Lumlertgul N, Pirondini L, Cooney E, Kok W, Gregson J, Camporota L, Lane K, Leach R, Ostermann M. Acute kidney injury prevalence, progression and long-term outcomes in critically ill patients with COVID-19: a cohort study. Ann Intensive Care. 2021 Aug 6;11(1):123. doi: 10.1186/s13613-021-00914-5.
- Individual participant dataSharing planned: Undecided
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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.
Nuttha Lumlertgul, MD, PhD principal investigator
Guy's & St Thomas' Hospital
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 COVID and Acute Kidney Injury, run by Guy's and St Thomas' NHS Foundation Trust 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlies Ostermann, MD, PhD (0044 207 188 3038 ext. 83036, Marlies.Ostermann@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any stage of acute kidney injury (time frame: 14 days). 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 NCT04445259, 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 4 Aug 2021.