Dialysis Weaning in Intensive Care Units (Dialysis STOP)

Acute Kidney Injury Clinical Trial

— D-STOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763188
• Other study ID #: AGros
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2020
• Source: Gros, Alexandre, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,...)

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• Use of daily urinary urea excretion
Weaning dialysis catheter

Locations

Country	Name	City	State
France	Alexandre Gros	Bordeaux	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Dr Alexandre Gros

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

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