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Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05973747
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Calcium Gluconate
  • Drug: Calcium chloride
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Calcium Gluconate

2 grams of calcium gluconate, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping

Drug: Calcium Gluconate
2 grams of calcium gluconate, infused intravenously over 10 minutes upon umbilical cord clamping
Active Comparator: Calcium Chloride

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

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

Outcome Measures

Primary Outcome Measures

  1. Serum ionized calcium concentration [Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion]

    Ionized calcium will be measured in each participant from a maximum of 6 venous blood draws of 0.5mL (1/10th of a teaspoon). 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 ionized blood calcium levels will be immediately analyzed using an Abbott iStat machine.

Secondary Outcome Measures

  1. Serum pH [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lucile Packard Children's Hospital Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Jessica Ansari, MD, MS, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jessica Ansari, MD, Clinical Assistant Professor of Anesthesiology, Stanford University
ClinicalTrials.gov Identifier:
NCT05973747
Other Study ID Numbers:
  • 70603
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Postpartum Hemorrhage
Hypocalcemia
Hemorrhage
Calcium, Dietary
Calcium

Study Results

No Results Posted as of Aug 3, 2023