NCT04799600

Brief Summary

Aim of the study is to determinate the frequency of acute renal failure in COVID-19 patients, its relationship with the severity of COVID-19 disease in ICU, and the ability to take precautions against these factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

March 10, 2021

Last Update Submit

July 24, 2021

Conditions

COVID19Acute Renal Failure

Keywords

COVID19Acute Renal Failure

Outcome Measures

Primary Outcomes (2)

  • KDIGO criteria

    KDIGO Criteria stage 1: Increase in SCr by ≥ 0.3 mg/dL within 48 hours or increase in SCr 1.5 to 1.9 times baseline which is known or presumed to have occurred within the prior 7 days Stage 2: 2.0 to 2.9 multiplied by baseline SCr; Stage 3: 3.0 or more multiplied by baseline; increase in SCr ≥ 4.0 mg/dL; or beginning of renal replacement therapy regardless of a previous KDIGO stage.

    6 months

  • BRESCIA-COVID RESPIRATORY SEVERITY SCALE (BCRSS) scores

    The BCRSS score (between level 0-8) is calculated from "www.mdcalc.com/brescia-covid-respiratory-severity-scale-bcrss-algorithm" according to the severity of COVID disease , respiratory rate, PaO2 level, chest x-ray, and clinical status.

    6 months

Study Arms (1)

Acute Renal Failure in ICU

COVID-19 Patients with Acute Renal Failure in ICU

Other: BRESCİA-COVİD Respiratory Severity Scale

Interventions

BRESCİA-COVİD Respiratory Severity ScaleOTHER

KDIGO acute renal failure score BRESCİA-COVID Respiratory Severity Score

Acute Renal Failure in ICU

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalized in the intensive care unit diagnosed with COVID-19 will participate in the study.

You may qualify if:

  • Patients hospitalized in the intensive care unit diagnosed with COVID-19 will include in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

  • Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.

    PMID: 23394211RESULT

  • Wang L, Li X, Chen H, Yan S, Li D, Li Y, Gong Z. Coronavirus Disease 19 Infection Does Not Result in Acute Kidney Injury: An Analysis of 116 Hospitalized Patients from Wuhan, China. Am J Nephrol. 2020;51(5):343-348. doi: 10.1159/000507471. Epub 2020 Mar 31.

    PMID: 32229732RESULT

  • Rodriguez-Nava G, Yanez-Bello MA, Trelles-Garcia DP, Chung CW, Friedman HJ, Hines DW. Performance of the quick COVID-19 severity index and the Brescia-COVID respiratory severity scale in hospitalized patients with COVID-19 in a community hospital setting. Int J Infect Dis. 2021 Jan;102:571-576. doi: 10.1016/j.ijid.2020.11.003. Epub 2020 Nov 9.

    PMID: 33181332RESULT

MeSH Terms

Conditions

COVID-19Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • betül aytaç, MD

    ankara ch bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 16, 2021

Study Start

September 1, 2020

Primary Completion

June 15, 2021

Study Completion

July 1, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

TU(1)