Acute Kidney InjurySoVHIRRNCT05897840
Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
A study testing Fiber-optic probe CeVOX in people with Acute Kidney Injury, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Fiber-optic probe CeVOX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients requiring blood pressure monitoring
- Severe AKI treated by RRT
- Hemodynamic stability prior to initiation of RRT
- Patients aged above 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH of Montpellier
Montpellier, 34295
Eddine BENDIAB, Dr, 0467332495 ext. +33, e-bendiab@chu-montpellier.fr
Kada KLOUCHE, Pr, 0467338441 ext. +33, k-klouche@chu-montpellier.fr
About this study
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Fiber-optic probe CeVOX
- 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
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber-optic probe CeVOXDevice
Installation of the fiber-optic probe within the existing central venous catheter for continuous monitoring of SvcO2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fiber-optic probe CeVOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-28 days
Secondary outcomes (6)
Number of IDH during a RRT session
Number of IDH during a RRT session
Measured: 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
Measured: 1-28 days
Cardiac output variation
Variations in cardiac output measured continuously during the RRT session
Measured: 1-28 days
Pulse pressure variation
Value of the pulse pressure variation measured continuously during the RRT session
Measured: 1-28 days
RRT duration
RRT duration
Measured: 1-28 days
Mortality in the ICU
Mortality in the ICU
Measured: 1-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start4 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eddine BENDIAB, Dr, Principal investigator, Hospital of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897840
- Sponsor's protocol ID
- RECHMPL20_0411
- Acronym
- SoVHIRR
- Status last verified
- Sep 2023
- First submitted
- 1 Jun 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05897840
- Acronym / sponsor ID
- SoVHIRR / RECHMPL20_0411
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Continuous measurement of central venous oxygen saturation | Experimental | Device: Fiber-optic probe CeVOXThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Critically ill patients requiring blood pressure monitoring
- Severe AKI treated by RRT
- Hemodynamic stability prior to initiation of RRT
- Patients aged above 18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber-optic probe CeVOXInstallation of the fiber-optic probe within the existing central venous catheter for continuous monitoring of SvcO2 | Device | Continuous measurement of central venous oxygen saturation |
Primary outcome
Venous oxygen saturation measurement
Time frame: 1-28 days
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.
6 secondary outcomes
Number of IDH during a RRT session
Time frame: 1-28 days
IDH corrective measures
Time frame: 1-28 days
Cardiac output variation
Time frame: 1-28 days
Pulse pressure variation
Time frame: 1-28 days
RRT duration
Time frame: 1-28 days
Mortality in the ICU
Time frame: 1-28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddine BENDIAB, Dr principal investigator
Hospital of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber-optic probe CeVOX in people with Acute Kidney Injury, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eddine BENDIAB, Dr (0467332495 ext. +33, e-bendiab@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous oxygen saturation measurement (time frame: 1-28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.