Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy (PRELOAD-CRRT)
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|ClinicalTrials.gov Identifier: NCT03139123|
Recruitment Status : Not yet recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
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.
|Condition or disease||Intervention/treatment|
|Kidney Injury Renal Failure, Acute||Other: Hemodynamic monitoring during passive leg raising|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy|
|Estimated Study Start Date :||May 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||October 2018|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139123
|Contact: Jean-Christophe RICHARD, MD||04 72 07 17 62 ext +firstname.lastname@example.org|
|Service de réanimation médicale- Hôpital de la Croix-Rousse||Not yet recruiting|
|Lyon, France, 69004|
|Contact: Jean-Christophe RICHARD, MD 04 72 07 17 62 ext +33 email@example.com|
|Principal Investigator: Jean-Christophe RICHARD, MD|