Dialysis Weaning in Intensive Care Units (Dialysis STOP)

NCT03763188 | Completed DMC

• 1 other identifier: AGros
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• the catheter free days

  days

  the first 28 days after catheter insertion

Secondary Outcomes (8)

• new dialysis catheter and new renal replacement therapy

  the first 7 days after dialysis catheter ablation

• number of dialysis catheter laid per patients

  the first 28 days after catheter insertion

• Duration of renal replacement therapy

  the first 28 days after catheter insertion

• Renal therapy replacement complications (hemorrhage, heparin-induced thrombocytopenia, other)

  the first 28 days after catheter insertion

• Dialysis catheters infections

  the first 28 days after catheter insertion

Study Arms (2)

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

Interventions

Use of daily urinary urea excretion OTHER

Weaning dialysis catheter

the group AFTER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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,...)

Sponsors & Collaborators

• Dr Alexandre Gros: lead

Study Sites (1)

Alexandre Gros

Bordeaux, Aquitaine, 33000, France

Location

Related Publications (2)

• 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.

  PMID: 26895760 BACKGROUND

• Bodot S, Gros A, Le Gall L, Martin A, Gisbert-Mora C, Pillot J, Ragot C, Grand H, Romen A, Masri A, Dewitte A, Gruson D, Prevel R, Rubin S, Orieux A, Boyer A. Effects of the urinary urea excretion index on the decision to wean ICU patients with acute kidney injury from renal replacement therapy: a before-after multicentre study (D-STOP). Crit Care. 2025 Jul 1;29(1):261. doi: 10.1186/s13054-025-05289-8.

  PMID: 40598590 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: GROS, Alexandre, Medical Doctor, Intensive Care Unit, Principal Investigator

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 4, 2018
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)