Acute Kidney InjuryEarly DryNCT05119361
Early Dry Cohort : Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit.
An observational study of Acute Kidney Injury, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). 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?
- Early Dry protocol
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 1 Sep 2021
- 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: Adult Patients in intensive care unit with acute kidney injury with continuous renal replacement therapy and fluid overload, with hemodynamic instability
Who may be able to join
- - Age ≥ 18 ans
- Acute kidney injury with continuous renal replacement therapy
- Fluid overload > 5%
- Equivalent Norepinephrine dose < 0,5 µg/kg/min
Who cannot join
- - Chronic intermittent haemodialysis
- Active bleeding
- Stroke with coma
- Pregnancy
- advanced directives to withhold or withdraw life-sustaining treatment
- patient's opposition to the use of his/her personal health data."
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. A Before-after Study.
Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.
We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.
- Conditions
- Acute Kidney Injury
- Being tested
- Early Dry protocol
- Keywords
- ultrafiltration, deresuscitation, fluid overload, fluid balance.
- Medical subject headings
- Acute Kidney Injury, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Dry protocolOther
After meeting eligibility criteria, patients have a net ultrafiltration of 2mL/kg/h with systematic perfusion monitoring (lactate concentration, central venous saturation, mottling score and capillary refill time) and restrictive input.
If the patient presents hypoperfusion (at least to sign), net ultrafiltration is stopped and haemodynamic optimized.
If the patient presents pulmonary oedema or right ventricular failure, with venous congestion, ultrafiltration is set at 3mL/kg/h.
Ultrafiltration is set between 0.5 and 1mL/kg/h when the following criteria are fulfilled: weight inferior to the admission weight; central venous pressure inferior to 5mmHg; absence of clinical oedema.
The haemodynamic status is reevaluated all six hours.
| Study group | Role | What they receive |
|---|---|---|
| before protocol implementation | A control group reflecting usual practice about net ultrafiltration and deresuscitation strategy in patients with continuous renal replacement therapy in our Department.
All patients meeting eligibility criteria between 01/01/2020 and 31/12/2021 will be include. Receives: Other: Early Dry protocol | |
| after protocol implementation | All patients treated by our deresuscitation protocol between 15/02/2020 and 15/08/2021 will be included. Receives: Other: Early Dry protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computed cumulative fluid balance (mL) at day 5 after protocol onset.
Cumulative between input and output, defined as follow:
- Input = cumulative volume of:
- Medication
- Enteral and parenteral feeding
- Fluid loading
- Transfusion products
- Output = cumulative volume of:
- diuresis
- surgical drainage
- net ultrafiltration
Measured: Day 5 after protocol onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Jul 2021
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119361
- Sponsor's protocol ID
- 454
- Acronym
- Early Dry
- Status last verified
- Mar 2022
- First submitted
- 2 Nov 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. A Before-after Study.
- ClinicalTrials.gov ID
- NCT05119361
- Acronym / sponsor ID
- Early Dry / 454
- Conditions
- Acute Kidney Injury
- Keywords
- ultrafiltration, deresuscitation, fluid overload, fluid balance.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 15 Nov 2021 (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.
Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.
We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before protocol implementation | – | Other: Early Dry protocolA control group reflecting usual practice about net ultrafiltration and deresuscitation strategy in patients with continuous renal replacement therapy in our Department. All patients meeting eligibility criteria between 01/01/2020 and 31/12/2021 will be include. |
| after protocol implementation | – | Other: Early Dry protocolAll patients treated by our deresuscitation protocol between 15/02/2020 and 15/08/2021 will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients in intensive care unit with acute kidney injury with continuous renal replacement therapy and fluid overload, with hemodynamic instability
Key inclusion criteria (4 listed)
- - Age ≥ 18 ans
- Acute kidney injury with continuous renal replacement therapy
- Fluid overload > 5%
- Equivalent Norepinephrine dose < 0,5 µg/kg/min
Key exclusion criteria (6 listed)
- - Chronic intermittent haemodialysis
- Active bleeding
- Stroke with coma
- Pregnancy
- advanced directives to withhold or withdraw life-sustaining treatment
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 |
|---|---|---|
| Early Dry protocolAfter meeting eligibility criteria, patients have a net ultrafiltration of 2mL/kg/h with systematic perfusion monitoring (lactate concentration, central venous saturation, mottling score and capillary refill time) and restrictive input. If the patient presents hypoperfusion (at least to sign), net ultrafiltration is stopped and haemodynamic optimized. If the patient presents pulmonary oedema or right ventricular failure, with venous congestion, ultrafiltration is set at 3mL/kg/h. Ultrafiltration is set between 0.5 and 1mL/kg/h when the following criteria are fulfilled: weight inferior to the admission weight; central venous pressure inferior to 5mmHg; absence of clinical oedema. The haemodynamic status is reevaluated all six hours. | Other | after protocol implementation, before protocol implementation |
Primary outcome
Computed cumulative fluid balance (mL) at day 5 after protocol onset.
Time frame: Day 5 after protocol onset.
Cumulative between input and output, defined as follow: * Input = cumulative volume of: * Medication * Enteral and parenteral feeding * Fluid loading * Transfusion products * Output = cumulative volume of: * diuresis * surgical drainage * net ultrafiltration
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 3 Mar 2022.
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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 Hospices Civils de Lyon 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 4 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 3 Mar 2022. 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?
Computed cumulative fluid balance (mL) at day 5 after protocol onset. (time frame: Day 5 after protocol onset.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022.