Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instabil… (NCT05897840) | Clinical Trial Compass
UnknownNot Applicable
Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
France100 participantsStarted 2023-09-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.