Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy (PRELOAD-CRRT)

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 Overview

• Status: Completed
• Conditions: Kidney Injury; Renal Failure, Acute
• Intervention / Treatment: Other: Hemodynamic monitoring during passive leg raising

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Service de réanimation médicale- Hôpital de la Croix-Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with acute kidney injury; Intensive care unit patients with acute kidney injury. Patients under continuous renal replacement therapy and hemodynamic monitoring.	Other: Hemodynamic monitoring during passive leg raising; Measurement of hypotensive episodes related to preload dependance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	7 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Actual): August 29, 2020
• Study Completion (Actual): November 21, 2020

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Hypotension
• Other Study ID Numbers: 69HCL17_0120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No