Calcium for Lowering Vasopressor use in cardiac surgery: a phase II feasibility trial

Calcium for Lowering Vasopressor use in cardiac surgery requiring cardiopulmonary bypass: a phase II feasibility trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626001127392

Acronym

CALVARY-II

Enrollment

112

Registered

2026-09-10

Start date

2027-01-30

Completion date

2027-12-31

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

After heart surgery, 30-90% of patients receiving medications to boost their blood pressure, which can lead to illness, death, and healthcare costs. In this study, we randomise patients to receive calcium infusions vs. a placebo (a lookalike medication with no effect) to assess if calcium can help reduce the burden of blood pressure boosting medications. We hypothesise that delivering calcium infusions in this trial is safe, and will show a preliminary signal in reducing vasopressor requirements.

Interventions

- Name: Calcium chloride infusion - Dose: 10% in normal saline, 60mls, refillable if required > Maximum possible dose: 72mls of 10% calcium chloride (48.96 mmol of elemental calcium) > Refills will be provided once the current 60mls syringe has been completely depleted. - Duration of treatment: 24 hours from initiation of cardiopulmonary bypass - Mode of delivery: Intravenous infusion - Adherence: Administered by trial staff and ICU nursing/medical teams. Infusion rates will be titrated based o

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age >=18 years 2. Elective cardiac surgery requiring cardiopulmonary bypass, including: - Coronary artery bypass grafting (CABG) - Valvular heart surgery - Combined CABG with valvular heart surgery - Aortic root surgery 3. Able to provide consent

Exclusion criteria

1. Emergency or redo surgery 2. Severe left ventricular dysfunction (ejection fraction 2.6 mmol/l or serum ionised calcium > 1.35 mmol/l) 3. End-stage kidney disease 4. Known hypercalcaemia (defined as serum calcium >2.6 mmol/l or serum ionised calcium > 1.35 mmol/l) 5. Known hyperparathyroidism (elevated intact parathyroid hormone in the presence of normal or raised serum calcium levels) 6. Participation in other interventional studies affecting calcium haemostasis 7. Allergy or known contraindication to study drug 8. Prior participation in CALVARY-II 9. Pregnancy

Outcome results