search
Back to results

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

Primary Purpose

Acute Kidney Injury

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fiber-optic probe CeVOX
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UH of MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Continuous measurement of central venous oxygen saturation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of IDH during a RRT session
Number of IDH during a RRT session
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
Cardiac output variation
Variations in cardiac output measured continuously during the RRT session
Pulse pressure variation
Value of the pulse pressure variation measured continuously during the RRT session
RRT duration
RRT duration
Mortality in the ICU
Mortality in the ICU

Full Information

First Posted
June 1, 2023
Last Updated
September 13, 2023
Sponsor
University Hospital, Montpellier
search

1. Study Identification

Unique Protocol Identification Number
NCT05897840
Brief Title
Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
Acronym
SoVHIRR
Official Title
Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous measurement of central venous oxygen saturation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fiber-optic probe CeVOX
Intervention Description
Installation of the fiber-optic probe within the existing central venous catheter for continuous monitoring of SvcO2
Primary Outcome Measure Information:
Title
Venous oxygen saturation measurement
Description
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.
Time Frame
1-28 days
Secondary Outcome Measure Information:
Title
Number of IDH during a RRT session
Description
Number of IDH during a RRT session
Time Frame
1-28 days
Title
IDH corrective measures
Description
Vascular filling, introduction or increase of the dose of vasopressor by more than 25% to maintain satisfactory blood pressure, discontinuation of ultrafiltration
Time Frame
1-28 days
Title
Cardiac output variation
Description
Variations in cardiac output measured continuously during the RRT session
Time Frame
1-28 days
Title
Pulse pressure variation
Description
Value of the pulse pressure variation measured continuously during the RRT session
Time Frame
1-28 days
Title
RRT duration
Description
RRT duration
Time Frame
1-28 days
Title
Mortality in the ICU
Description
Mortality in the ICU
Time Frame
1-28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eddine BENDIAB, Dr
Phone
0467332495
Ext
+33
Email
e-bendiab@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Kada KLOUCHE, Pr
Phone
0467338441
Ext
+33
Email
k-klouche@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddine BENDIAB, Dr
Organizational Affiliation
Hospital of Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddine BENDIAB, Dr
Phone
0467332495
Ext
+33
Email
e-bendiab@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Kada KLOUCHE, Pr
Phone
0467338441
Ext
+33
Email
k-klouche@chu-montpellier.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs