Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients

NCT05897840 | Unknown

• 1 other identifier: RECHMPL20_0411
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury (AKI) is common in intensive care unit (ICU) and inducing a high morbidity and mortality. In severe forms of AKI (more than 25% of AKI patients admitted to the ICU), renal replacement therapy (RRT) is often necessary. Although RRT is a cornerstone of therapy, it can lead to serious adverse effects, such as intradialytic arterial hypotension. Indeed, arterial hypotension during the session - intra-dialytic arterial hypotension (IDH) - occurs frequently complication and so regardless of the RRT modality used. Its occurrence may worsen significantly the outcome as previously reported. It is therefore of parmount importance to prevent such an adverse effect. The investigators hypothesize that a decrease in the central venous oxygen saturation (SvcO2) measured related to a decreased cardiac output could precede the onset of IDH. The aim of this study is collect IDH in AKI patients and to measure continuously SvcO2 during RRT session in order to investigate its role in predicting IDH.

Conditions

Acute Kidney Injury

Keywords

Hemodynamic instability related to renal replacement therapy; Continuous mixed venous central oxygen saturation; Intensive Care Unit; Sensibility; Specificity; Acute Kidney Injury; Renal replacement therapy; Intradialytic hypotension; Cardiac output

Outcome Measures

Primary Outcomes (1)

• Venous oxygen saturation measurement

  Venous oxygen saturation measured continuously during the RRT session in the critically ill patient. Intradialytic hypotension is defined as the occurrence of a decrease in systolic blood pressure below 90mmHg and/or a decrease in mean arterial pressure below 65mmHg that warrants therapeutic intervention (vascular filling, introduction or increase in the dose of vasopressor by more than 25% to maintain satisfactory blood pressure, discontinuation of ultrafiltration) during the RRT session.

  1-28 days

Secondary Outcomes (6)

• Number of IDH during a RRT session

  1-28 days

• IDH corrective measures

  1-28 days

• Cardiac output variation

  1-28 days

• Pulse pressure variation

  1-28 days

• RRT duration

  1-28 days

Study Arms (1)

Continuous measurement of central venous oxygen saturation

EXPERIMENTAL

The measurement of SvcO2 is performed by spectrophotometry which is a quantitative measurement of wavelength transmission. For this, a fiber optic probe, CeVOX probe, is used.

Device: Fiber-optic probe CeVOX

Interventions

Fiber-optic probe CeVOX DEVICE

Installation of the fiber-optic probe within the existing central venous catheter for continuous monitoring of SvcO2

Continuous measurement of central venous oxygen saturation

Eligibility Criteria

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

You may qualify if:

• Critically ill patients requiring blood pressure monitoring
• Severe AKI treated by RRT
• Hemodynamic stability prior to initiation of RRT
• Patients aged above 18 years

You may not qualify if:

• Pregnancy
• Major under tutorship or curatorship
• Patient is not beneficiary or affiliated with a social security plan
• Contraindication to placement of a venous catheter in the superior vena cava territory: thrombosis of the superior vena cava, thrombosis of the jugular and subclavian veins
• Chronic end-stage renal failure on chronic dialysis

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH of Montpellier

Montpellier, 34295, France

RECRUITING

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 Officials

• Eddine BENDIAB, Dr

  Hospital of Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eddine BENDIAB, Dr

CONTACT

0467332495; e-bendiab@chu-montpellier.fr

Kada KLOUCHE, Pr

CONTACT

0467338441; k-klouche@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Assessing the ability of continuously measured SvcO2 to predict the occurrence of IDH in critical patients suffering from an AKI for which RRT is necessary.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: September 4, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

FR (1)