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

Completed

• Conditions: Kidney Injury; Renal Failure, Acute
• Interventions: Other: Hemodynamic monitoring during passive leg raising

• Registration Number: NCT03139123
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-03
• Study Start: 2017-05-18
• Primary Completion: 2020-08-29
• Study Completion: 2020-11-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with acute kidney injury	Hemodynamic monitoring during passive leg raising	Intensive care unit patients with acute kidney injury. Patients under continuous renal replacement therapy and hemodynamic monitoring.

Primary Outcome Measures

Name	Time	Method
Presence of hypotensive episode by hemodynamic monitoring	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	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.

Trial Locations

Locations (1)

Service de réanimation médicale- Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France