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Completed

NCT Number: NCT03763188

Dialysis Weaning in Intensive Care Units (Dialysis STOP)

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandre Gros

Bordeaux, Aquitaine, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,...)

Treatment and study plan

Use of daily urinary urea excretion

Other

Weaning dialysis catheter

Primary outcomes

  1. the catheter free days

    Time frame: the first 28 days after catheter insertion

    days

Secondary outcomes

  1. new dialysis catheter and new renal replacement therapy

    Time frame: the first 7 days after dialysis catheter ablation

    number

  2. number of dialysis catheter laid per patients

    Time frame: the first 28 days after catheter insertion

    median

  3. Duration of renal replacement therapy

    Time frame: the first 28 days after catheter insertion

    days

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

    Time frame: the first 28 days after catheter insertion

    number

  5. Dialysis catheters infections

    Time frame: the first 28 days after catheter insertion

    number

  6. Duration of ICU stay

    Time frame: the first 28 days after catheter insertion

    days

  7. Duration of mechanical ventilation

    Time frame: the first 28 days after catheter insertion

    days

  8. Mortality at at day 28

    Time frame: the first 28 days after catheter insertion

    number

Sponsors and collaborators

Lead sponsor

Dr Alexandre Gros

Indiv

Registry information

Official study title

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

Acronym: D-STOP

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2018
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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