Clinical trial NCT03763188: Dialysis Weaning in Intensive Care Units (Dialysis STOP)
Official title: Daily Urinary Urea Excretion to Guide Renal Replacement Therapy Weaning in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Gros, Alexandre, M.D.
Sponsor class: INDIV
First posted: 2018-12-04
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients \> 18 years of age, admitted to intensive care unit, who have a RRT for AKI.

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.

Eligibility criteria: 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,...)

Primary outcomes:
measure: the catheter free days
timeFrame: the first 28 days after catheter insertion
Secondary outcomes:
measure: new dialysis catheter and new renal replacement therapy
timeFrame: the first 7 days after dialysis catheter ablation
measure: number of dialysis catheter laid per patients
timeFrame: the first 28 days after catheter insertion
measure: Duration of renal replacement therapy
timeFrame: the first 28 days after catheter insertion
measure: Renal therapy replacement complications (hemorrhage, heparin-induced thrombocytopenia, other)
timeFrame: the first 28 days after catheter insertion
measure: Dialysis catheters infections
timeFrame: the first 28 days after catheter insertion
measure: Duration of ICU stay
timeFrame: the first 28 days after catheter insertion
measure: Duration of mechanical ventilation
timeFrame: the first 28 days after catheter insertion
measure: Mortality at at day 28
timeFrame: the first 28 days after catheter insertion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Alexandre Gros
state: Aquitaine
Study officials:
References:
citation: 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.