Protocol to Assess the Severity of Acute Kidney Injury

NCT ID: NCT00673244

Last Updated: 2022-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The principal objective is to safely determine if we can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled, we will draw blood and urine for relevant biomarkers. Our goal is to validate if any of these biomarkers can predict the course of AKI (recovery v. RRT v. death)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

AKI is a very common disease in the intensive care unit. However, despite advances in supportive care, patients with AKI carry a high mortality rate (50% to 70%). The established AKI affects nearly 5 percent of hospitalized persons and as many as 15 percent of critically ill patients. Currently, there are no FDA approved therapeutic agents for the treatment of AKI.

Retrospective studies suggest that the early initiation of renal replacement therapy (RRT) improves outcome. Many clinicians tend to take a "wait and see" approach because they do not want to dialyze a patient who is destined to recover renal function without the need for RRT. Therefore, it is vitally important to know early in the course which patients with AKI are likely to progress to RRT.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Furosemide

One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lasix

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years and older
* Increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater or equal to 150 to 200% from baseline or sustained oliguria(mean urine output of \<0.5 cc/kg/hr for 6 hours within 48 hours)
* Written informed consent
* Patients who already have a indwelling bladder catheter

Exclusion Criteria

* Voluntary refusal or missing written consent of the patient or the designated legal representative
* Patients with advanced Chronic Kidney Disease - as defined by a baseline GFR of \< 30 ml/min as calculated by the MDRD equation
* Patients with renal transplantation
* Pregnancy
* Patients with an allergy or sensitivity to loop diuretics
* Patients with a clinical syndrome consistent with pre-renal AKI

* Defined by fractional excretion of Na of \< 1% AND no evidence of the urinary casts, or
* Patients that are under-resuscitated as deemed by treating clinical team or
* Patients who are actively bleeding
* Patients with a clinical syndrome of post-renal AKI

* Any radiological study that shows hydro-ureter, or
* Clinical scenario wherein the obstruction is considered a likely possibility of the cause of AKI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

George Washington University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lakmir S Chawla, MD

Role: PRINCIPAL_INVESTIGATOR

George Washigton University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

George Washington University Hospital

Washington D.C., District of Columbia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Hou SH, Bushinsky DA, Wish JB, Cohen JJ, Harrington JT. Hospital-acquired renal insufficiency: a prospective study. Am J Med. 1983 Feb;74(2):243-8. doi: 10.1016/0002-9343(83)90618-6.

Reference Type BACKGROUND
PMID: 6824004 (View on PubMed)

Liu KD, Himmelfarb J, Paganini E, Ikizler TA, Soroko SH, Mehta RL, Chertow GM. Timing of initiation of dialysis in critically ill patients with acute kidney injury. Clin J Am Soc Nephrol. 2006 Sep;1(5):915-9. doi: 10.2215/CJN.01430406. Epub 2006 Jul 6.

Reference Type BACKGROUND
PMID: 17699307 (View on PubMed)

PARSONS FM, HOBSON SM, BLAGG CR, McCRACKEN BH. Optimum time for dialysis in acute reversible renal failure. Description and value of an improved dialyser with large surface area. Lancet. 1961 Jan 21;1(7169):129-34. doi: 10.1016/s0140-6736(61)91309-5. No abstract available.

Reference Type BACKGROUND
PMID: 13733013 (View on PubMed)

Fischer RP, Griffen WO Jr, Reiser M, Clark DS. Early dialysis in the treatment of acute renal failure. Surg Gynecol Obstet. 1966 Nov;123(5):1019-23. No abstract available.

Reference Type BACKGROUND
PMID: 5926520 (View on PubMed)

Kleinknecht D, Jungers P, Chanard J, Barbanel C, Ganeval D. Uremic and non-uremic complications in acute renal failure: Evaluation of early and frequent dialysis on prognosis. Kidney Int. 1972 Mar;1(3):190-6. doi: 10.1038/ki.1972.26. No abstract available.

Reference Type BACKGROUND
PMID: 4545907 (View on PubMed)

Conger JD. A controlled evaluation of prophylactic dialysis in post-traumatic acute renal failure. J Trauma. 1975 Dec;15(12):1056-63. doi: 10.1097/00005373-197512000-00003. No abstract available.

Reference Type BACKGROUND
PMID: 1202238 (View on PubMed)

Gettings LG, Reynolds HN, Scalea T. Outcome in post-traumatic acute renal failure when continuous renal replacement therapy is applied early vs. late. Intensive Care Med. 1999 Aug;25(8):805-13. doi: 10.1007/s001340050956.

Reference Type BACKGROUND
PMID: 10447537 (View on PubMed)

Demirkilic U, Kuralay E, Yenicesu M, Caglar K, Oz BS, Cingoz F, Gunay C, Yildirim V, Ceylan S, Arslan M, Vural A, Tatar H. Timing of replacement therapy for acute renal failure after cardiac surgery. J Card Surg. 2004 Jan-Feb;19(1):17-20. doi: 10.1111/j.0886-0440.2004.04004.x.

Reference Type BACKGROUND
PMID: 15108784 (View on PubMed)

Elahi MM, Lim MY, Joseph RN, Dhannapuneni RR, Spyt TJ. Early hemofiltration improves survival in post-cardiotomy patients with acute renal failure. Eur J Cardiothorac Surg. 2004 Nov;26(5):1027-31. doi: 10.1016/j.ejcts.2004.07.039.

Reference Type BACKGROUND
PMID: 15519198 (View on PubMed)

Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.

Reference Type BACKGROUND
PMID: 15312219 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB# 010835

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Immune Function in Acute Kidney Injury
NCT02470507 ACTIVE_NOT_RECRUITING
Prospective Validation of AKI Prediction
NCT06804200 NOT_YET_RECRUITING