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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Injury Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Failure, Acute Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de réanimation médicale- Hôpital de la Croix-Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemodynamic monitoring during passive leg raising

Other

Measurement of hypotensive episodes related to preload dependance.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PRELOAD-CRRT

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: May 3, 2017
Registry last updated: Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed