HypervolemiaPhase 4OFFLOAD-SHOCKNCT07756801
Capital Offload-Shock
A Phase 4 study testing Immediate renal replacement therapy in people with Hypervolemia and Cardiogenic Shock, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypervolemia, Cardiogenic Shock, Renal Replacement Therapies
- What is being tested?
- Immediate renal replacement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to Sep 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Hannah Feagan, RN, 613-696-7000, hfeagan@ottawaheart.ca
Simon Parlow, MD FRCPC
About this study
Official title: Optimal Timing of Renal Replacement Therapy in Hypervolemic Cardiogenic Shock
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.
Read the detailed description
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.
- Conditions
- Hypervolemia, Cardiogenic Shock, Renal Replacement Therapies
- Being tested
- Immediate renal replacement therapy
- Medical subject headings
- Edema, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate renal replacement therapyDrug
Renal replacement therapy started within 6 hours of randomization
| Study group | Role | What they receive |
|---|---|---|
| Immediate Renal Replacement Therapy | Experimental | Participants receive renal replacement therapy within 2-6 hours of randomization. Receives: Drug: Immediate renal replacement therapy |
| Standard Medical Treatment | No intervention | Participants will receive the standard of care medical therapy with discouragement of renal replacement therapy unless medically necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Occurrences of death from any cause
Measured: Baseline to 90 days
Increased serum lactate
Serum lactate greater than 3.5 mmol/L between 6 and 24 hours after randomization
Measured: Randomization to 24 hours post randomization.
Mechanical circulatory support
New need for, or replacement of, a mechanical circulatory support device.
Measured: Baseline to Hospital Discharge - expected up to 90 days
Resuscitated cardiac arrest
Occurrences of resuscitated cardiac arrest
Measured: Baseline to Hospital Discharge - expected up to 90 days
Secondary outcomes (10)
Continued renal replacement therapy
Renal replacement therapy dependence for participants at discharge from index hospitalization
Measured: Baseline to Hospital Discharge - expected up to 90 days
Length of hospital stay
Number of days spent in hospital
Measured: 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
Measured: 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)
Measured: Baseline to Hospital Discharge - expected up to 90 days
All-cause mortality
Occurrences of death due to any cause
Measured: Baseline to Hospital Discharge - expected up to 90 days
Ventilator free days
Number of ventilation free days
Measured: Baseline to 90 days
Re-hospitalization
Re-admission to hospital for any reason
Measured: Baseline to 90 days
Renal replacement therapy dependence
Renal replacement therapy dependence among participants to end of follow up.
Measured: Baseline to 90 days
Days out of hospital
The median number of days spent out of hospital
Measured: Baseline to 90 days
Quality of Life Evaluation
Median scores of the EuroQoL 5D (dimensions). Higher scores indicate better perceived health.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypervolemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, open-label, randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Parlow, MD, FRCPC, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756801
- Sponsor's protocol ID
- 20260483-01T
- Acronym
- OFFLOAD-SHOCK
- Status last verified
- May 2026
- First submitted
- 17 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Renal Replacement Therapy in Hypervolemic Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07756801
- Acronym / sponsor ID
- OFFLOAD-SHOCK / 20260483-01T
- Conditions
- Hypervolemia, Cardiogenic Shock, Renal Replacement Therapies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 11 Aug 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center, open-label, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Immediate Renal Replacement Therapy | Experimental | Drug: Immediate renal replacement therapyParticipants receive renal replacement therapy within 2-6 hours of randomization. |
| Standard Medical Treatment | No intervention | –Participants will receive the standard of care medical therapy with discouragement of renal replacement therapy unless medically necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Immediate renal replacement therapyRenal replacement therapy started within 6 hours of randomization | Drug | Immediate Renal Replacement Therapy |
Primary outcome
All cause mortality
Time frame: Baseline to 90 days
Occurrences of death from any cause
Increased serum lactate
Time frame: Randomization to 24 hours post randomization.
Serum lactate greater than 3.5 mmol/L between 6 and 24 hours after randomization
Mechanical circulatory support
Time frame: Baseline to Hospital Discharge - expected up to 90 days
New need for, or replacement of, a mechanical circulatory support device.
Resuscitated cardiac arrest
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Occurrences of resuscitated cardiac arrest
10 secondary outcomes
Continued renal replacement therapy
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Length of hospital stay
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Length of intensive care unit stay
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Major bleeding events
Time frame: Baseline to Hospital Discharge - expected up to 90 days
All-cause mortality
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Ventilator free days
Time frame: Baseline to 90 days
Re-hospitalization
Time frame: Baseline to 90 days
Renal replacement therapy dependence
Time frame: Baseline to 90 days
Days out of hospital
Time frame: Baseline to 90 days
Quality of Life Evaluation
Time frame: Baseline to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
Simon Parlow, MD, FRCPC principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immediate renal replacement therapy in people with Hypervolemia and Cardiogenic Shock, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 24 Sep 2026. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Feagan, RN (613-696-7000, hfeagan@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Baseline to 90 days). The study lists 4 primary outcomes in all. 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 24 Sep 2026.