NCT04445259

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

June 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

2.1 years

First QC Date

May 27, 2020

Last Update Submit

August 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of any stage of acute kidney injury

    As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria

    14 days

Secondary Outcomes (8)

  • Mortality

    14-day, hospital, and intensive care unit (ICU) mortality

  • Renal recovery

    14 days

  • Percentage of patients who receive renal replacement therapy

    14 days

  • Percentage of participants who are dialysis dependent

    Through study completion, an average of 90 days

  • Free-days of vasoactive medications and mechanical ventilation

    Day 30

  • +3 more secondary outcomes

Study Arms (1)

Critically Ill Patients with COVID-19

We plan to recruit patients who are admitted to intensive care units with COVID-19 diagnosis.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult critically ill patients with confirmed diagnosis of COVID-19

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

  • Lumlertgul 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.

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nuttha Lumlertgul, MD, PhD

    Guy's & St Thomas' Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlies Ostermann, MD, PhD

CONTACT

Nuttha Lumlertgul, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 24, 2020

Study Start

June 20, 2020

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

August 4, 2021

Record last verified: 2021-08

Locations