CAPITAL OFFLOAD-SHOCK (NCT07756801) | Clinical Trial Compass
Not Yet RecruitingPhase 4
CAPITAL OFFLOAD-SHOCK
Canada456 participantsStarted 2026-09-01
Plain-language summary
CAPITAL OFFLOAD-SHOCK will aim to answer if early use of renal replacement therapy, like dialysis, in patients with reduced body fluids causing the heart to be unable to pump enough blood through the body reduces in-hospital death when compared to the current standard of care. The current standard of care is to wait until renal replacement therapy is clinically necessary.
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:
* adult patients \>/= 18 years of age admitted to an intensive care unit
* Diagnosed clinically with Society for Cardiovascular Angiography and Interventions (SCAI) Class C or D cardiogenic shock
* Clinical or hemodynamic evidence of volume overload
Exclusion Criteria:
* Patients whose care plan, as determined by the treating clinical team, will not include renal replacement therapy
* Decision has already been made by the treating clinical team to initiate renal replacement therapy
* Hyperkalemia with serum potassium \>/= 6mmol/L at the time of screening
* Severe metabolic acidosis with serum bicarbonate \</= 12 mmol/L at the time of screening
* Severe azotemia with serum urea \>/= 40 mmol/L at the time of screening
* Acute intoxication necessitating use of renal replacement therapy
* Recent renal replacement therapy (within 30 days)
* Known end-stage renal disease (defined as an estimated glomerular filtration rate \<15 ml/min/1.73m2
* presentation with out-of-hospital cardiac arrest
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.
What they're measuring
1
All cause mortality
Timeframe: Baseline to 90 days
2
Increased Serum Lactate
Timeframe: Randomization to 24 hours post randomization.
3
Mechanical Circulatory Support
Timeframe: Baseline to Hospital Discharge - expected up to 90 days
4
Resuscitated cardiac arrest
Timeframe: Baseline to Hospital Discharge - expected up to 90 days
Trial details
NCT IDNCT07756801
SponsorOttawa Heart Institute Research Corporation