Dialysis Weaning in Intensive Care Units (Dialysis STOP) (D-STOP)

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

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).

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Use of daily urinary urea excretion

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 Type: Observational
• Enrollment (Actual): 260

Contacts and Locations

Study Locations

• France
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33000
      • Alexandre Gros

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients > 18 years of age, admitted to intensive care unit, who have a RRT for AKI.

Description

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,...)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the group BEFORE; Retrospective group. The daily urinary urea excretion was unknown.
the group AFTER; Prospective group. Use the daily urinary urea excretion to guide the renal replacement therapy weaning.	Other: Use of daily urinary urea excretion; Weaning dialysis catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the catheter free days	days	the first 28 days after catheter insertion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr Alexandre Gros

Publications and helpful links

General Publications

• Aniort J, Ait Hssain A, Pereira B, Coupez E, Pioche PA, Leroy C, Heng AE, Souweine B, Lautrette A. Daily urinary urea excretion to guide intermittent hemodialysis weaning in critically ill patients. Crit Care. 2016 Feb 19;20:43. doi: 10.1186/s13054-016-1225-5.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 15, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: AGros

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No