Kidney InjuryPRELOAD-CRRTNCT03139123
Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy
An observational study of Kidney Injury and Renal Failure, Acute, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Injury, Renal Failure, Acute
- What is being tested?
- Hemodynamic monitoring during passive leg raising
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2017to 21 Nov 2020
- 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: This study concerns patients hospitalized in intensive care unit at the Croix-Rousse hospital in Lyon with acute renal insufficiency (stage 3 of the Kidney Disease: Improving Global Outcomes classification) for which treatment with continuous hemofiltration was initiated less than 24 hours ago and for whom a hemodynamic monitoring device (PiCCO® device) has been implanted due to acute circulatory failure and is functional.
Who may be able to join
- Intensive Care Unit patients with acute kidney injury
- under continuous renal replacement therapy initiated since less than 24 hours
- under hemodynamic monitoring by the PiCCO® device.
Who cannot join
- lower limb amputation
- inferior vena cava compression
- intracranial hypertension
- age below 18 year
- pregnancy
- advance directives to withhold or withdraw life sustaining treatment,
Show all 10Show fewer
- lack of written informed consent by patient or next of kin
- lack of affiliation to social security as required by French regulation
- patient under a legal protective measure
- previous inclusion in current study
Trial locations and contacts
1 site in 1 country.
France1 site
Service de réanimation médicale- Hôpital de la Croix-Rousse
Lyon, 69004
About this study
Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. New diagnostic methods are now available with high reliability to identify hypovolemia as the underlying cause of hypotension, among which change in cardiac index during passive leg raising may be the less affected by restrictive validity criteria. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.
The aim of this study is then to identify, among hypotensive episodes occurring during renal replacement therapy in Intensive Care Unit patients, the percentage of episodes related to preload dependence as identified by passive leg raising.
- Conditions
- Kidney Injury, Renal Failure, Acute
- Being tested
- Hemodynamic monitoring during passive leg raising
- 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.
Hemodynamic monitoring during passive leg raisingOther
Measurement of hypotensive episodes related to preload dependance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute kidney injury | Intensive care unit patients with acute kidney injury. Patients under continuous renal replacement therapy and hemodynamic monitoring. Receives: Other: Hemodynamic monitoring during passive leg raising |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of hypotensive episode by hemodynamic monitoring
An hypotensive episode is defined as mean arterial pressure < 65 mm Hg and one of the following events :
- Fluid administration
- OR increase of vasopressor dose
- OR decrease of fluid removal
Measured: 7 days
Preload dependence identified by cardiac index greater than 10% during passive leg raising
The passive leg raising allows to identify the percentage of hypotensive episodes related to preload dependence.
A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start18 May 2017
- Primary completion29 Aug 2020
- Study completion21 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 42 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
- NCT03139123
- Sponsor's protocol ID
- 69HCL17_0120
- Acronym
- PRELOAD-CRRT
- Status last verified
- Jan 2021
- First submitted
- 27 Apr 2017
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bitker L, Biscarrat C, Yonis H, Chivot M, Chauvelot L, Chazot G, Mezidi M, Deniel G, Richard JC. Determinants of Urine Output Using Advanced Hemodynamic Monitoring in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy. Blood Purif. 2024;53(3):189-199. doi: 10.1159/000535544. Epub 2023 Dec 16.
PubMed 38104538
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT03139123
- Acronym / sponsor ID
- PRELOAD-CRRT / 69HCL17_0120
- Conditions
- Kidney Injury, Renal Failure, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 29 Aug 2020 (actual)
- Study completion
- 21 Nov 2020 (actual)
- First posted
- 3 May 2017 (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.
Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. New diagnostic methods are now available with high reliability to identify hypovolemia as the underlying cause of hypotension, among which change in cardiac index during passive leg raising may be the less affected by restrictive validity criteria. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.
The aim of this study is then to identify, among hypotensive episodes occurring during renal replacement therapy in Intensive Care Unit patients, the percentage of episodes related to preload dependence as identified by passive leg raising.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute kidney injury | – | Other: Hemodynamic monitoring during passive leg raisingIntensive care unit patients with acute kidney injury. Patients under continuous renal replacement therapy and hemodynamic monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns patients hospitalized in intensive care unit at the Croix-Rousse hospital in Lyon with acute renal insufficiency (stage 3 of the Kidney Disease: Improving Global Outcomes classification) for which treatment with continuous hemofiltration was initiated less than 24 hours ago and for whom a hemodynamic monitoring device (PiCCO® device) has been implanted due to acute circulatory failure and is functional.
Key inclusion criteria (3 listed)
- Intensive Care Unit patients with acute kidney injury
- under continuous renal replacement therapy initiated since less than 24 hours
- under hemodynamic monitoring by the PiCCO® device.
Key exclusion criteria (10 listed)
- lower limb amputation
- inferior vena cava compression
- intracranial hypertension
- age below 18 year
- pregnancy
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 |
|---|---|---|
| Hemodynamic monitoring during passive leg raisingMeasurement of hypotensive episodes related to preload dependance. | Other | Patients with acute kidney injury |
Primary outcome
Presence of hypotensive episode by hemodynamic monitoring
Time frame: 7 days
An hypotensive episode is defined as mean arterial pressure < 65 mm Hg and one of the following events : * Fluid administration * OR increase of vasopressor dose * OR decrease of fluid removal
Preload dependence identified by cardiac index greater than 10% during passive leg raising
Time frame: 7 days
The passive leg raising allows to identify the percentage of hypotensive episodes related to preload dependence. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.
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 25 Jan 2021.
- Derived from this study: PubMed 38104538Bitker L, Biscarrat C, Yonis H, Chivot M, Chauvelot L, Chazot G, Mezidi M, Deniel G, Richard JC. Determinants of Urine Output Using Advanced Hemodynamic Monitoring in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy. Blood Purif. 2024;53(3):189-199. doi: 10.1159/000535544. Epub 2023 Dec 16.
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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 Kidney Injury and Renal Failure, Acute, 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 3 inclusion and 10 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 25 Jan 2021. 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?
Presence of hypotensive episode by hemodynamic monitoring (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT03139123, which also lists 1 linked publication.
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 25 Jan 2021.