MedTrace Logo

Artificial Kidney Initiation in Kidney Injury

NCT01932190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2016-06-24

No results posted yet for this study

Summary

The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:

1. an "early" strategy where RRT is started immediately when a RIFLE F status is documented
2. a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration \> 40 mmol /L, serum potassium concentration \> 6 mmol /L, serum potassium concentration \> 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH \< 7.15 in the context of pure metabolic acidosis (PaCO2 \<35 mmHg) or in the context of mixed acidosis with PaCO2\> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow\> 5L/min in spontaneously breathing patients or FiO2\> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2\> 95%, despite diuretic therapy.

The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.

Conditions

  • Renal Replacement Therapy for Acute Kidney Injury in Intensive Care Unit

Interventions

PROCEDURE

Early RRT strategy

the "early" strategy : RRT is started immediately when a RIFLE F status is documented

PROCEDURE

Delayed RRT strategy

The "delayed" strategy : RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the "Alert Criteria": see summary

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Didier DREYFUSS, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01932190 on ClinicalTrials.gov