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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Device: Fiber-optic probe CeVOX

Detailed Description

In ICU settings, about 25% of AKI patients underwent RRT. RRT leads to certain complications, the most frequent and severe of which is IDH. The frequency of IDH varies from 10 to 70% and from 19 to 43% in intermittent and continuous RRT respectively.

The occurrence of IDH worsens the prognosis of critically ill patients. It may impair the recovery of renal function and is associated with increased mortality. Thus, early detection of IDH requires the development of preventive strategies and the implementation of adapted curative therapies.

IDH results from several mechanisms. The main mechanisms involved is hypovolemia leading to cardiac dysfunction, but also cardiac dysfunction not related to hypovolemia.

The identification of tools correlated with cardiac output could allow early prediction of IDH. Yet, no tool has been evaluated to predict the occurrence of IDH.

Central venous oxygen saturation (SvcO2) is a reflection of the balance between systemic O2 transport and tissue O2 consumption and thus is the indicator of cardiac output. A decrease in cardiac output leads to a decrease in SvcO2 to enhance O2 transport and to maintain arterial pressure. Assuming that O2 extraction is constant, SvcO2 would then be a surrogate for cardiac output. A decrease in SvcO2 may reflect a decrease in cardiac output before IDH occurs.

There are very few data in the literature evaluating changes in cardiac output during an RRT session. Continuous measurement of SvcO2, a minimally invasive and indirect marker of cardiac output, during an RRT session has never been reported to predict IDH.

The investigators hypothesize that a decrease in SvcO2, indicative of decreased cardiac output, should precede the onset of IDH.

In order to evaluate this hypothesis, the investigators intend to measure continuous SvcO2 and continuous cardiac output during the first three RRT sessions, regardless of the RRT modality.

The investigators will assess the performance of SvcO2 values and other invasive hemodynamic parameters in predicting the occurrence of IDH using ROC curves. Once the composite score has been constructed, an optimal threshold will be determined using Youden's J statistic. Determination of the 95% confidence interval (95% CI), sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Comparison of areas under the curve using Delong's non-parametric approach.

Patients will be monitored until they are discharged from intensive care, intensive care, death or D28 max.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eddine BENDIAB, Dr; Phone Number: +33 0467332495; Email: e-bendiab@chu-montpellier.fr
• Study Contact Backup: Name: Kada KLOUCHE, Pr; Phone Number: +33 0467338441; Email: k-klouche@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UH of Montpellier
    • Contact: Eddine BENDIAB, Dr; Phone Number: +33 0467332495; Email: e-bendiab@chu-montpellier.fr
    • Contact: Kada KLOUCHE, Pr; Phone Number: +33 0467338441; Email: k-klouche@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy
• Major under tutorship or curatorship
• Refusal of the patient or trusted person/family (if present) to sign the informed consent or to confirm participation in the case of emergency inclusion
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous measurement of central venous oxygen saturation; 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; Installation of the fiber-optic probe within the existing central venous catheter for continuous monitoring of SvcO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of IDH during a RRT session	Number of IDH during a RRT session	1-28 days
IDH corrective measures	Vascular filling, introduction or increase of the dose of vasopressor by more than 25% to maintain satisfactory blood pressure, discontinuation of ultrafiltration	1-28 days
Cardiac output variation	Variations in cardiac output measured continuously during the RRT session	1-28 days
Pulse pressure variation	Value of the pulse pressure variation measured continuously during the RRT session	1-28 days
RRT duration	RRT duration	1-28 days
Mortality in the ICU	Mortality in the ICU	1-28 days

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Eddine BENDIAB, Dr, Hospital of Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Cardiac output; Renal replacement therapy; Acute Kidney Injury; Intradialytic hypotension; Specificity; Sensibility; Hemodynamic instability related to renal replacement therapy; Continuous mixed venous central oxygen saturation
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: RECHMPL20_0411

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No