Clinical trial NCT05973747: Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients
Official title: Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Postpartum Hemorrhage
Pregnancy Related
Hypocalcemia
Parturition Complication
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g)
timeFrame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
measure: Clearance from first to second compartment (L/min)
timeFrame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
measure: Volume of distribution of first compartment of pharmacokinetic model (L)
timeFrame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
measure: Clearance from second compartment (L/min)
timeFrame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
measure: Volume of distribution of second compartment of pharmacokinetic model (L)
timeFrame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
Secondary outcomes:
measure: Serum pH
timeFrame: Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
measure: Baseline serum ionized calcium concentration
timeFrame: Baseline prior to calcium infusion
measure: Peak change in serum ionized calcium concentration (mmol/L)
timeFrame: Measured immediately at completion of the 10-minute calcium infusion.
measure: Time to half of peak change in ionized calcium (minutes)
timeFrame: 10-60 minutes after infusion initiation
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Jessica Ansari, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: