Cardiogenic Shock, Hypervolemia, Renal Replacement Therapy
Conditions
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.
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 F1O2 \> 50% 2. hyperkalemia with serum potassium \>6mmol/L 3. Severe metabolic acidosis with pH \<7.2 and bicarb \<12 mmol/L thought to be due to renal insufficiency.
Interventions
DRUGImmediate renal replacement therapy
Renal replacement therapy started within 6 hours of randomization
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multi-center, open-label, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | Baseline to 90 days | Occurrences of death from any cause |
| Increased Serum Lactate | Randomization to 24 hours post randomization. | Serum lactate greater than 3.5mmol/L between 6 and 24hours after randomization |
| Mechanical Circulatory Support | Baseline to Hospital Discharge - expected up to 90 days | New need for, or replacement of, a mechanical circulatory support device. |
| Resuscitated cardiac arrest | Baseline to Hospital Discharge - expected up to 90 days | Occurrences of resuscitated cardiac arrest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continued renal replacement therapy | Baseline to Hospital Discharge - expected up to 90 days | Renal replacement therapy dependence for participants at discharge from index hospitalization |
| Length of hospital stay | Baseline to Hospital Discharge - expected up to 90 days | Number of days spent in hospital |
| Length of intensive care unit stay | Baseline to Hospital Discharge - expected up to 90 days | The number of days spent in the intensive care unit during index hospitalization |
| Major bleeding events | Baseline to Hospital Discharge - expected up to 90 days | Bleeding events defined as the Bleeding Academic Research Consortium (BARC) type 3 or higher) |
| All-cause mortality | Baseline to Hospital Discharge - expected up to 90 days | Occurrences of death due to any cause |
| Ventilator free days | Baseline to 90 days | Number of ventilation free days |
| Re-hospitalization | Baseline to 90 days | Re-admission to hospital for any reason. |
| Renal Replacement Therapy dependence | Baseline to 90 days | Renal replacement therapy dependence among participants to end of follow up. |
| Days out of hospital | Baseline to 90 days | The median number of days spent out of hospital |
| Quality of Life Evaluation | Baseline to 90 days | Median scores of the EuroQoL 5D (dimensions). Higher scores indicate better perceived health. |
Countries
Canada
Contacts
CONTACTHannah Feagan, RN
PRINCIPAL_INVESTIGATORSimon Parlow, MD, FRCPC
Ottawa Heart Institute Research Corporation
Outcome results
None listed