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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03139123
Collaborator
(none)
42
1
42.2
1

Study Details

Study Description

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 Phase
  • Other: Hemodynamic monitoring during passive leg raising

Study Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy
Actual Study Start Date :
May 18, 2017
Actual Primary Completion Date :
Aug 29, 2020
Actual Study Completion Date :
Nov 21, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de réanimation médicale- Hôpital de la Croix-Rousse Lyon France 69004

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03139123
Other Study ID Numbers:
  • 69HCL17_0120
First Posted:
May 3, 2017
Last Update Posted:
Jan 25, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2021