Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-19

Study Completion Date

2023-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Postpartum Hemorrhage Pregnancy Related Hypocalcemia Parturition Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Calcium Gluconate

Intervention Type DRUG

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.

Calcium Chloride

0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping

Group Type ACTIVE_COMPARATOR

Calcium chloride

Intervention Type DRUG

0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping

Interventions

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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.

Intervention Type DRUG

Calcium chloride

0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Pregnant female subjects delivering at the study institution via scheduled cesarean delivery at term (\>=37 weeks gestation)

Exclusion Criteria

1. severe range blood pressure (BP \>160/\>110) within the 48 hours prior to delivery
2. patient age \<18 years or \>45 years
3. renal dysfunction with serum Cr \> 1.0 mg/dL
4. known history of congenital or acquired cardiac disease or history of arrhythmia
5. patient taking digoxin
6. patient currently taking a calcium channel blocker
7. Weight \<55kg or \>100kg, or
8. receiving magnesium infusion within 24 hours prior to or during cesarean delivery
9. administration of intraoperative doses of calcium by the anesthesiology team for clinical indications

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes