Skip to content

Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy

Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03139123
Acronym
PRELOAD-CRRT
Enrollment
42
Registered
2017-05-03
Start date
2017-05-18
Completion date
2020-11-21
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Injury, Renal Failure, Acute

Brief 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. 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.

Interventions

OTHERHemodynamic monitoring during passive leg raising

Measurement of hypotensive episodes related to preload dependance.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* lower limb amputation * inferior vena cava compression * intracranial hypertension * age below 18 year * pregnancy * advance directives to withhold or withdraw life sustaining treatment, * 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 * inclusion in another research study

Design outcomes

Primary

MeasureTime frameDescription
Presence of hypotensive episode by hemodynamic monitoring7 daysAn 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 raising7 daysThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026