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

NCT03139123 | Completed

• 1 other identifier: 69HCL17_0120
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Injury; Renal Failure, Acute

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

Hemodynamic monitoring during passive leg raising OTHER

Measurement of hypotensive episodes related to preload dependance.

Patients with acute kidney injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de réanimation médicale- Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Related Publications (1)

• Bitker L, Biscarrat C, Yonis H, Chivot M, Chauvelot L, Chazot G, Mezidi M, Deniel G, Richard JC. Determinants of Urine Output Using Advanced Hemodynamic Monitoring in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy. Blood Purif. 2024;53(3):189-199. doi: 10.1159/000535544. Epub 2023 Dec 16.

  PMID: 38104538 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 3, 2017
• Study Start: May 18, 2017
• Primary Completion: August 29, 2020
• Study Completion: November 21, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

FR (1)