Capital Offload-Shock
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Immediate renal replacement therapy
DrugRenal replacement therapy started within 6 hours of randomization
Treatment groups
456 Participants
are divided into 2 treatment groupsGroup A: Immediate Renal Replacement TherapyExperimental treatment 1 intervention
Group B: Standard Medical TreatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
All cause mortality
Occurrences of death from any cause
Time frame
Baseline to 90 days2
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.3
Mechanical circulatory support
New need for, or replacement of, a mechanical circulatory support device.
Time frame
Baseline to Hospital Discharge - expected up to 90 days4
Resuscitated cardiac arrest
Occurrences of resuscitated cardiac arrest
Time frame
Baseline to Hospital Discharge - expected up to 90 daysSecondary outcomes
1
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 days2
Length of hospital stay
Number of days spent in hospital
Time frame
Baseline to Hospital Discharge - expected up to 90 days3
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 days4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: