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

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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

Tracking Information
First Submitted Date May 27, 2020
First Posted Date June 24, 2020
Last Update Posted Date June 24, 2020
Actual Study Start Date June 20, 2020
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2020)
Incidence of any stage of acute kidney injury [ Time Frame: 14 days ]
As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 23, 2020)
  • Mortality [ Time Frame: 14-day, hospital, and intensive care unit (ICU) mortality ]
    Mortality
  • Renal recovery [ Time Frame: 14 days ]
    Defined by return of creatinine to < 1.5 times of baseline
  • Percentage of patients who receive renal replacement therapy [ Time Frame: 14 days ]
    Percentage
  • Percentage of participants who are dialysis dependent [ Time Frame: Through study completion, an average of 90 days ]
    Percentage of participants who are dialysis dependent
  • Free-days of vasoactive medications and mechanical ventilation [ Time Frame: Day 30 ]
    Days without vasoactive medications and mechanical ventilation
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
Official Title Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult critically ill patients with confirmed diagnosis of COVID-19
Condition
  • COVID
  • Acute Kidney Injury
  • Critical Illness
Intervention Not Provided
Study Groups/Cohorts Critically Ill Patients with COVID-19
We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 23, 2020)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
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
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04445259
Other Study ID Numbers 283672
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Guy's and St Thomas' NHS Foundation Trust
Study Sponsor Guy's and St Thomas' NHS Foundation Trust
Collaborators Harvard Medical School
Investigators
Principal Investigator: Nuttha Lumlertgul, MD, PhD Guy's & St Thomas' Hospital
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date May 2020