Renal Outcome of Acute Kidney Disease

NCT03597854 | Unknown

• 1 other identifier: 2017-234-DM-EXP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Both, acute kidney injury (AKI) and chronic kidney disease (CKD) considered as a continuum of the disease process. The renal recovery after AKI is currently assessed by measuring serum creatinine, which has its limitations including change in muscle mass, volume distribution in critically ill patients. Also, despite complete return of serum creatinine after AKI, these patients remain at increased risk for developing CKD, which suggest that there may be persistent subclinical damage to the kidney. The new term acute kidney disease (AKD) has been proposed to define the renal disease after AKI. Recently (2017), Acute Disease Quality Initiative (ADQI) 16 workgroup published a consensus document on AKD and renal recovery, which provide definition as well as research recommendation for AKD. The consensus report of the ADQI 16 workgroup (2017) recommended that there is need for studies to describe the epidemiology, clinical course, natural history of patients having AKD; and also determine optimal methods to assess functional recovery and identify novel biomarker(s), functional tests, and imaging approach which can reveal ongoing injury and repair in these patients. This is an observational study to describe epidemiology, clinical course and recovery from AKD at 90 days in critically ill patients.

Conditions

Acute Kidney Disease

Keywords

Acute kidney disease; critically ill

Outcome Measures

Primary Outcomes (1)

• To know renal outcome of acute kidney disease (AKD) among ICU survivors at 90 days after exposure to an acute kidney injury initiating event.

  To study the renal outcome of AKD (among survivors) at 90 days, by measuring serum creatinine.

  90 days after exposure to an acute kidney injury initiating event.

Secondary Outcomes (1)

• Incidence of acute kidney disease (AKD) among ICU patients

  15 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult ICU patients who had AKD (at 7 days after exposure to an AKI initiating event) will be considered for inclusion.

You may qualify if:

• All ICU patients who are ≥18 years and had AKD

You may not qualify if:

• Age \<18 years
• Not known AKI initiating event day
• Any known renal disease (like CKD, nephritic or nephrotic syndrome)
• Pregnancy

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Department of Critical Care Medicine, SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

Related Publications (1)

• Chawla LS, Bellomo R, Bihorac A, Goldstein SL, Siew ED, Bagshaw SM, Bittleman D, Cruz D, Endre Z, Fitzgerald RL, Forni L, Kane-Gill SL, Hoste E, Koyner J, Liu KD, Macedo E, Mehta R, Murray P, Nadim M, Ostermann M, Palevsky PM, Pannu N, Rosner M, Wald R, Zarbock A, Ronco C, Kellum JA; Acute Disease Quality Initiative Workgroup 16.. Acute kidney disease and renal recovery: consensus report of the Acute Disease Quality Initiative (ADQI) 16 Workgroup. Nat Rev Nephrol. 2017 Apr;13(4):241-257. doi: 10.1038/nrneph.2017.2. Epub 2017 Feb 27.

  PMID: 28239173 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohan Gurjar, MD, PDCC

  SGPGIMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohan Gurjar, MD, PDCC

CONTACT

+91-522-249-5403; m.gurjar@rediffmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 24, 2018
• Study Start: June 28, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

IN (1)