Trials / Completed
CompletedNCT05973747
Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Calcium is a life saving medicine in the care of parturients. It has many important uses including treatment of hypocalcemia, treatment of magnesium toxicity, prevention of hypocalcemia during blood transfusion (of citrate containing blood products), treatment of hyperkalemia, and others. Recent clinical trials also suggest that calcium given after cord clamping may decrease blood loss in patients undergoing cesarean delivery. 2 FDA approved forms of calcium can be given intravenously: calcium chloride and calcium gluconate. Over the last decade there have been times with drug shortages of either calcium chloride or calcium gluconate. So there have been and likely will continue to be times when one formulation or the other may not be adequately available. Despite the importance of calcium and the frequency in which it is used in parturients, there are no published studies in parturients to determine dose equivalence between calcium gluconate and calcium chloride. In this study the investigators will determine the population pharmacokinetics of calcium gluconate and calcium chloride in parturients and calculate the dose equivalent ratio the two drugs. This will help clinicians select appropriate doses of calcium and provide resilience to the drug supply chain in our era of frequent drug shortages.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Calcium Gluconate | Infused intravenously over 10 minutes upon umbilical cord clamping. First 10 assigned patients received 2 grams per protocol. Subsequent 13 patients received 1.5 grams, dose recalibrated per protocol. |
| DRUG | Calcium chloride | 0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping |
Timeline
- Start date
- 2023-08-19
- Primary completion
- 2023-12-15
- Completion
- 2023-12-15
- First posted
- 2023-08-03
- Last updated
- 2024-04-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05973747. Inclusion in this directory is not an endorsement.