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

NCT ID: NCT03139123

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-18

Study Completion Date

2020-11-21

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Injury Renal Failure, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with acute kidney injury

Intensive care unit patients with acute kidney injury. Patients under continuous renal replacement therapy and hemodynamic monitoring.

Hemodynamic monitoring during passive leg raising

Intervention Type OTHER

Measurement of hypotensive episodes related to preload dependance.

Interventions

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Hemodynamic monitoring during passive leg raising

Measurement of hypotensive episodes related to preload dependance.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de réanimation médicale- Hôpital de la Croix-Rousse

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 38104538 (View on PubMed)

Other Identifiers

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69HCL17_0120

Identifier Type: -

Identifier Source: org_study_id

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