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Clinical Trials/NCT03763188
NCT03763188CompletedNot Applicable

Daily Urinary Urea Excretion to Guide Renal Replacement Therapy Weaning in Intensive Care Units

Dr Alexandre Gros1 site in 1 country260 target enrollmentStarted: September 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
260
Locations
1
Primary Endpoint
the catheter free days

Study Overview

Brief Summary

Evaluation of daily urinary urea excretion, to guide Renal Replacement Therapy weaning, in Intensive Care Units.

The objective is to show that remove the dialysis catheter, once daily urinary urea excretion is greater than 1.35 mmol/kg/d, would increase more than 3 days the number without dialysis catheters, and thus without dialysis, the first 28 days after insertion.

Daily urinary urea excretion = urea (mmol/L) x diuresis (L/d) / weight (kg).

Detailed Description

Daily urinary excretion of urea may provide a safe and reproducible renal replacement therapy withdrawal criterion, according to a recent French study (citations). A rate greater than 1.35 mmol/kg/d would predict a weaning success of 97.1% at 1 week. This criterion is influenced by the use of diuretics, and is easily accessible and achievable. Daily urinary urea excretion is representative of the recovery of renal function. The French study establishing this new withdrawal criterion was monocentric and retrospective. However, we changed our practices as soon as we became aware of them.

French multicentric (Bordeaux University Hospital, Libourne, Pau and Bayonne Hospitals) study, before and after:

  • Period before: patients who were dialysed in the intensive care units of Bordeaux, Libourne, Pau and Bayonne, from November 2013 to November 2015.
  • Period after: patients selected prospectively in the 4 hospitals.

When diuresis > 100 ml/d, an urinary ionogram is realized daily. Measurement of urinary urea excretion every day. Ablation of the catheter as soon as daily urinary urinary excretion > 1.35 mmol/kg/d.

Measurement of daily urinary excretion the following 3 days.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients > 18 of age, who have a Renal Replacement Therapy, in intensive care unit,
  • with a diuresis > 100 ml/d.

Exclusion Criteria

  • Patients still presenting "hard" criteria for RRT: metabolic acidosis with pH < 7.15 and PCO2 <50mmHg; acute pulmonary edema (> 5l 02 or 50% FiO2 for Sp02 > 95%) objectified by echocardiography; K> 5.5 mmol/l after treatment
  • Renal transplantation
  • Long-term chronic kidney injury or short-term dialysis project (arteriovenous fistula created).
  • Acute Kidney Injury secondary to thrombotic microangiopathy
  • Acute Kidney Injury secondary to an obstacle even if dialysed
  • RRT started for toxic cause without IRA (lithium,...)

Outcomes

Primary Outcomes

the catheter free days

Time Frame: the first 28 days after catheter insertion

days

Secondary Outcomes

  • Renal therapy replacement complications (hemorrhage, heparin-induced thrombocytopenia, other)(the first 28 days after catheter insertion)
  • number of dialysis catheter laid per patients(the first 28 days after catheter insertion)
  • new dialysis catheter and new renal replacement therapy(the first 7 days after dialysis catheter ablation)
  • Dialysis catheters infections(the first 28 days after catheter insertion)
  • Duration of renal replacement therapy(the first 28 days after catheter insertion)
  • Duration of mechanical ventilation(the first 28 days after catheter insertion)
  • Duration of ICU stay(the first 28 days after catheter insertion)
  • Mortality at at day 28(the first 28 days after catheter insertion)

Investigators

Sponsor
Dr Alexandre Gros
Sponsor Class
Indiv
Responsible Party
Sponsor Investigator
Principal Investigator

Dr Alexandre Gros

GROS, Alexandre, Medical Doctor, Intensive Care Unit, Principal Investigator

Gros, Alexandre, M.D.

Study Sites (1)

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