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Completed

NCT Number: NCT05973747

Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

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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Key information

Conditions

Postpartum Hemorrhage Calcium Metabolism Disorders Female Urogenital Diseases and Pregnancy Complications Hemorrhage Hypocalcemia Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Parturition Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Related Puerperal Disorders Urogenital Diseases Uterine Hemorrhage Water-Electrolyte Imbalance

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Calcium Gluconate

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

Drug

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

Primary outcomes

  1. Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g)

    Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion

    Calculated via NONMEM

  2. Clearance from first to second compartment (L/min)

    Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion

    Determined using population pharmacokinetic analysis in NONMEM

  3. Volume of distribution of first compartment of pharmacokinetic model (L)

    Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion

    Determined using population pharmacokinetic analysis in NONMEM

  4. Clearance from second compartment (L/min)

    Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion

    Determined using population pharmacokinetic analysis in NONMEM

  5. Volume of distribution of second compartment of pharmacokinetic model (L)

    Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion

    Determined using population pharmacokinetic analysis in NONMEM

Secondary outcomes

  1. Serum pH

    Time frame: Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion

    Serum pH will be measured in each participant from a maximum of 6 venous blood draws of 0.5mL (1/10th of a teaspoon). These blood draws will be the same blood draws used to measure serum ionized calcium concentration, no additional blood draws will be necessary. These draws will occur at the following target times: prior to calcium administration, at 6 minutes, 10 minutes, 15 minutes, minutes, minutes after beginning calcium administration. The serum pH levels will be immediately analyzed using an Abbott iStat machine.

  2. Baseline serum ionized calcium concentration

    Time frame: Baseline prior to calcium infusion

    Ionized calcium will be measured in each participant prior to administration of the 10-minute calcium infusion. The ionized blood calcium levels will be immediately analyzed using an Abbott iStat machine.

  3. Peak change in serum ionized calcium concentration (mmol/L)

    Time frame: Measured immediately at completion of the 10-minute calcium infusion.

    Measured via venous blood draw and an Abbott iStat CG8+ cartridge

  4. Time to half of peak change in ionized calcium (minutes)

    Time frame: 10-60 minutes after infusion initiation

    A two-compartment model does not lend itself to a meaningful half-life approximation. However, the time to serum values measuring 1/2 of the peak change in ionized calcium can be calculated from the pharmacokinetic model

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2023
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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