CAPITAL OFFLOAD-SHOCK

NCT07756801 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 20260483-01T
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypervolemia; Cardiogenic Shock; Renal Replacement Therapy

Outcome Measures

Primary Outcomes (4)

• All cause mortality

  Occurrences of death from any cause

  Baseline to 90 days

• Increased Serum Lactate

  Serum lactate greater than 3.5mmol/L between 6 and 24hours after randomization

  Randomization to 24 hours post randomization.

• Mechanical Circulatory Support

  New need for, or replacement of, a mechanical circulatory support device.

  Baseline to Hospital Discharge - expected up to 90 days

• Resuscitated cardiac arrest

  Occurrences of resuscitated cardiac arrest

  Baseline to Hospital Discharge - expected up to 90 days

Secondary Outcomes (10)

• Continued renal replacement therapy

  Baseline to Hospital Discharge - expected up to 90 days

• Length of hospital stay

  Baseline to Hospital Discharge - expected up to 90 days

• Length of intensive care unit stay

  Baseline to Hospital Discharge - expected up to 90 days

• Major bleeding events

  Baseline to Hospital Discharge - expected up to 90 days

• All-cause mortality

  Baseline to Hospital Discharge - expected up to 90 days

Study Arms (2)

Immediate Renal Replacement Therapy

EXPERIMENTAL

Participants receive renal replacement therapy within 2-6 hours of randomization.

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.

Interventions

Immediate renal replacement therapy DRUG

Renal replacement therapy started within 6 hours of randomization

Immediate Renal Replacement Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Edema; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Shock

Study Officials

• Simon Parlow, MD, FRCPC

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Feagan, RN

CONTACT

613-696-7000; hfeagan@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center, open-label, randomized controlled trial.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 11, 2026

Record last verified: 2026-05

Locations

CA (1)