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Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445259
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief 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.

Condition or disease
COVID Acute Kidney Injury Critical Illness

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
Actual Study Start Date : June 20, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Group/Cohort
Critically Ill Patients with COVID-19
We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis.



Primary Outcome Measures :
  1. Incidence of any stage of acute kidney injury [ Time Frame: 14 days ]
    As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 14-day, hospital, and intensive care unit (ICU) mortality ]
    Mortality

  2. Renal recovery [ Time Frame: 14 days ]
    Defined by return of creatinine to < 1.5 times of baseline

  3. Percentage of patients who receive renal replacement therapy [ Time Frame: 14 days ]
    Percentage

  4. Percentage of participants who are dialysis dependent [ Time Frame: Through study completion, an average of 90 days ]
    Percentage of participants who are dialysis dependent

  5. Free-days of vasoactive medications and mechanical ventilation [ Time Frame: Day 30 ]
    Days without vasoactive medications and mechanical ventilation

  6. Length of intensive care unit and hospital stay [ Time Frame: Through study completion, an average of 90 days ]
    Length of intensive care unit and hospital stay

  7. Number of participants with consequences following AKI [ Time Frame: Through study completion, an average of 90 days ]
    Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumonia

  8. Time from illness onset to need for mechanical ventilator support [ Time Frame: Through study completion, an average of 30 days ]
    Time from illness onset to need for mechanical ventilator support



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult critically ill patients with confirmed diagnosis of COVID-19
Criteria

Inclusion Criteria:

  1. Adults (aged ≥18 years)
  2. Confirmed diagnosis of COVID-19
  3. Hospitalized in the ICU for illness related to COVID-19
  4. 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

Exclusion Criteria:

  1. Younger than 18 years old
  2. On chronic dialysis within the last year or on dialysis at ICU admission
  3. Functioning kidney transplant
  4. No creatinine within 48 hours of ICU admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445259


Contacts
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Contact: Marlies Ostermann, MD, PhD 0044 207 188 3038 ext 83036 Marlies.Ostermann@gstt.nhs.uk
Contact: Nuttha Lumlertgul, MD, PhD 0044 207 188 3038 ext 83036 Nuttha.Lumlertgul@gstt.nhs.uk

Locations
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United Kingdom
Guy's & St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Marlies Ostermann, MD, PhD    020 71883038    Marlies.Ostermann@gstt.nhs.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Harvard Medical School
Investigators
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Principal Investigator: Nuttha Lumlertgul, MD, PhD Guy's & St Thomas' Hospital
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04445259    
Other Study ID Numbers: 283672
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Critical Illness
Wounds and Injuries
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases