Acute Kidney InjuryD-STOPNCT03763188
Dialysis Weaning in Intensive Care Units (Dialysis STOP)
An observational study of Acute Kidney Injury, run by Dr Alexandre Gros at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Use of daily urinary urea excretion
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2016to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients > 18 years of age, admitted to intensive care unit, who have a RRT for AKI.
Who may be able to join
- All patients > 18 of age, who have a Renal Replacement Therapy, in intensive care unit,
- with a diuresis > 100 ml/d.
Who cannot join
- 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,...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Use of daily urinary urea excretion
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of daily urinary urea excretionOther
Weaning dialysis catheter
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Use of daily urinary urea excretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
the catheter free days
days
Measured: the first 28 days after catheter insertion
Secondary outcomes (8)
new dialysis catheter and new renal replacement therapy
number
Measured: the first 7 days after dialysis catheter ablation
number of dialysis catheter laid per patients
median
Measured: the first 28 days after catheter insertion
Duration of renal replacement therapy
days
Measured: the first 28 days after catheter insertion
Renal therapy replacement complications (hemorrhage, heparin-induced thrombocytopenia, other)
number
Measured: the first 28 days after catheter insertion
Dialysis catheters infections
number
Measured: the first 28 days after catheter insertion
Duration of ICU stay
days
Measured: the first 28 days after catheter insertion
Duration of mechanical ventilation
days
Measured: the first 28 days after catheter insertion
Mortality at at day 28
number
Measured: the first 28 days after catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Sep 2016
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Alexandre Gros
- Responsible party
- Sponsor-investigator, Dr Alexandre Gros, Gros, Alexandre, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763188
- Sponsor's protocol ID
- AGros
- Acronym
- D-STOP
- Status last verified
- Mar 2020
- First submitted
- 29 Nov 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26895760Bodot 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.
PubMed 40598590
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Urinary Urea Excretion to Guide Renal Replacement Therapy Weaning in Intensive Care Units
- ClinicalTrials.gov ID
- NCT03763188
- Acronym / sponsor ID
- D-STOP / AGros
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Dr Alexandre Gros
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the group BEFORE | – | –Retrospective group. The daily urinary urea excretion was unknown. |
| the group AFTER | – | Other: Use of daily urinary urea excretionProspective group. Use the daily urinary urea excretion to guide the renal replacement therapy weaning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients > 18 years of age, admitted to intensive care unit, who have a RRT for AKI.
Key inclusion criteria (2 listed)
- All patients > 18 of age, who have a Renal Replacement Therapy, in intensive care unit,
- with a diuresis > 100 ml/d.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of daily urinary urea excretionWeaning dialysis catheter | Other | the group AFTER |
Primary outcome
the catheter free days
Time frame: the first 28 days after catheter insertion
days
8 secondary outcomes
new dialysis catheter and new renal replacement therapy
Time frame: the first 7 days after dialysis catheter ablation
number of dialysis catheter laid per patients
Time frame: the first 28 days after catheter insertion
Duration of renal replacement therapy
Time frame: the first 28 days after catheter insertion
Renal therapy replacement complications (hemorrhage, heparin-induced thrombocytopenia, other)
Time frame: the first 28 days after catheter insertion
Dialysis catheters infections
Time frame: the first 28 days after catheter insertion
Duration of ICU stay
Time frame: the first 28 days after catheter insertion
Duration of mechanical ventilation
Time frame: the first 28 days after catheter insertion
Mortality at at day 28
Time frame: the first 28 days after catheter insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 26895760Aniort 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.
- Derived from this study: PubMed 40598590Bodot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Dr Alexandre Gros at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the catheter free days (time frame: the first 28 days after catheter insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03763188, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.