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

Kidney Injury Clinical Trial

— PRELOAD-CRRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139123
• Other study ID #: 69HCL17_0120
• Status: Completed
• Start date: May 18, 2017
• Est. completion date: November 21, 2020

Study information

• Verified date: January 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 21, 2020
• Est. primary completion date: August 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hypotension
• Kidney Injury
• Renal Failure, Acute

Intervention

Other:
• Hemodynamic monitoring during passive leg raising
Measurement of hypotensive episodes related to preload dependance.

Locations

Country	Name	City	State
France	Service de réanimation médicale- Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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