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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Kidney Injury Renal Failure, Acute Other: Hemodynamic monitoring during passive leg raising

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Jean-Christophe RICHARD, MD 04 72 07 17 62 ext +33 j-christophe.richard@chu-lyon.fr

Locations
France
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    j-christophe.richard@chu-lyon.fr   
Principal Investigator: Jean-Christophe RICHARD, MD         
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03139123     History of Changes
Other Study ID Numbers: 69HCL17_0120
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Renal Insufficiency
Hypotension
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases