A Phase 4 interventional study of Immediate renal replacement therapy in Hypervolemia, Cardiogenic Shock and Renal Replacement Therapies, sponsored by Ottawa Heart Institute Research Corporation. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Ottawa Heart Institute Research Corporation · Phase 4, Interventional, and Treatment
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.
The trial will evaluate the in-hospital mortality between starting renal replacement therapy (RRT) immediately upon confirmation of eligibility and consent and using standard medical therapy without RRT unless one of the following occurs: 1) clinical volume overload refractory to diuresis with high-dose intravenous furosemide plus either thiazide-like diuretic and/or acetazolamide, resulting in pulmonary edema, necessitation ventilation with FiO2 > 50%, 2) hyperkalemia with serum potassium >6mmol/L, or 3) severe metabolic acidosis with pH \<7.20 and bicarb \<=12 mmol/L thought to be due to renal insufficiency.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's planned enrollment of 456 is above the median of 52 across 401 interventional studies indexed under Edema.
Browse Edema studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive renal replacement therapy within 2-6 hours of randomization.
Drug: Immediate renal replacement therapy
Participants will receive the standard of care medical therapy with discouragement of renal replacement therapy unless medically necessary.
Renal replacement therapy started within 6 hours of randomization
All cause mortality
Occurrences of death from any cause
Time frame: Baseline to 90 days
Increased serum lactate
Serum lactate greater than 3.5 mmol/L between 6 and 24 hours after randomization
Time frame: Randomization to 24 hours post randomization.
Mechanical circulatory support
New need for, or replacement of, a mechanical circulatory support device.
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Resuscitated cardiac arrest
Occurrences of resuscitated cardiac arrest
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Continued renal replacement therapy
Renal replacement therapy dependence for participants at discharge from index hospitalization
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Length of hospital stay
Number of days spent in hospital
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Length of intensive care unit stay
The number of days spent in the intensive care unit during index hospitalization
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Major bleeding events
Bleeding events defined as the Bleeding Academic Research Consortium (BARC) type 3 or higher)
Time frame: Baseline to Hospital Discharge - expected up to 90 days
All-cause mortality
Occurrences of death due to any cause
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Ventilator free days
Number of ventilation free days
Time frame: Baseline to 90 days
Re-hospitalization
Re-admission to hospital for any reason
Time frame: Baseline to 90 days
Renal replacement therapy dependence
Renal replacement therapy dependence among participants to end of follow up.
Time frame: Baseline to 90 days
Days out of hospital
The median number of days spent out of hospital
Time frame: Baseline to 90 days
Quality of Life Evaluation
Median scores of the EuroQoL 5D (dimensions). Higher scores indicate better perceived health.
Time frame: Baseline to 90 days
Start is estimated for Dec 2026; primary completion for Sep 2027, 9 months later.
Of 28 phase 4 interventional studies under Edema, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 74. This study's planned 9 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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