University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Location contact
Hannah Feagan, RN
CONTACT
Simon Parlow, MD FRCPC
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07756801
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Ottawa, Ontario, K1Y 4W7, Canada
Hannah Feagan, RN
CONTACT
Simon Parlow, MD FRCPC
PRINCIPAL_INVESTIGATOR
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Renal replacement therapy started within 6 hours of randomization
Time frame: Baseline to 90 days
Occurrences of death from any cause
Time frame: Randomization to 24 hours post randomization.
Serum lactate greater than 3.5mmol/L between 6 and 24hours after randomization
Time frame: Baseline to Hospital Discharge - expected up to 90 days
New need for, or replacement of, a mechanical circulatory support device.
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Occurrences of resuscitated cardiac arrest
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Renal replacement therapy dependence for participants at discharge from index hospitalization
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Number of days spent in hospital
Time frame: Baseline to Hospital Discharge - expected up to 90 days
The number of days spent in the intensive care unit during index hospitalization
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)
Time frame: Baseline to Hospital Discharge - expected up to 90 days
Occurrences of death due to any cause
Time frame: Baseline to 90 days
Number of ventilation free days
Time frame: Baseline to 90 days
Re-admission to hospital for any reason.
Time frame: Baseline to 90 days
Renal replacement therapy dependence among participants to end of follow up.
Time frame: Baseline to 90 days
The median number of days spent out of hospital
Time frame: Baseline to 90 days
Median scores of the EuroQoL 5D (dimensions). Higher scores indicate better perceived health.
Contact information is provided by the study sponsor or research team.
Ottawa Heart Institute Research Corporation
Other
Optimal Timing of Renal Replacement Therapy in Hypervolemic Cardiogenic Shock
Acronym: OFFLOAD-SHOCK
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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