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NCT Number: NCT07756801

CAPITAL OFFLOAD-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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location contact

Hannah Feagan, RN

CONTACT

[email protected]

613-696-7000

Simon Parlow, MD FRCPC

PRINCIPAL_INVESTIGATOR

About this study

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:

  • 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 F1O2 > 50%
  • hyperkalemia with serum potassium >6mmol/L
  • Severe metabolic acidosis with pH <7.2 and bicarb <12 mmol/L thought to be due to renal insufficiency.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate renal replacement therapy

Drug

Renal replacement therapy started within 6 hours of randomization

Primary outcomes

  1. All cause mortality

    Time frame: Baseline to 90 days

    Occurrences of death from any cause

  2. Increased Serum Lactate

    Time frame: Randomization to 24 hours post randomization.

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

  3. 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.

  4. Resuscitated cardiac arrest

    Time frame: Baseline to Hospital Discharge - expected up to 90 days

    Occurrences of resuscitated cardiac arrest

Secondary outcomes

  1. Continued renal replacement therapy

    Time frame: Baseline to Hospital Discharge - expected up to 90 days

    Renal replacement therapy dependence for participants at discharge from index hospitalization

  2. Length of hospital stay

    Time frame: Baseline to Hospital Discharge - expected up to 90 days

    Number of days spent in hospital

  3. Length of intensive care unit stay

    Time frame: Baseline to Hospital Discharge - expected up to 90 days

    The number of days spent in the intensive care unit during index hospitalization

  4. Major bleeding events

    Time frame: Baseline to Hospital Discharge - expected up to 90 days

    Bleeding events defined as the Bleeding Academic Research Consortium (BARC) type 3 or higher)

  5. All-cause mortality

    Time frame: Baseline to Hospital Discharge - expected up to 90 days

    Occurrences of death due to any cause

  6. Ventilator free days

    Time frame: Baseline to 90 days

    Number of ventilation free days

  7. Re-hospitalization

    Time frame: Baseline to 90 days

    Re-admission to hospital for any reason.

  8. Renal Replacement Therapy dependence

    Time frame: Baseline to 90 days

    Renal replacement therapy dependence among participants to end of follow up.

  9. Days out of hospital

    Time frame: Baseline to 90 days

    The median number of days spent out of hospital

  10. Quality of Life Evaluation

    Time frame: Baseline to 90 days

    Median scores of the EuroQoL 5D (dimensions). Higher scores indicate better perceived health.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Feagan, RN

CONTACT

[email protected]

613-696-7000

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

Optimal Timing of Renal Replacement Therapy in Hypervolemic Cardiogenic Shock

Acronym: OFFLOAD-SHOCK

Important dates

Study start
2026
Primary completion
2027
Study completion
2031
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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