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Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

Primary Purpose

Postpartum Hemorrhage, Pregnancy Related, Hypocalcemia

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calcium Gluconate
Calcium chloride
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Lucile Packard Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Calcium Gluconate

Calcium Chloride

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum ionized calcium concentration
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

Serum pH
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.

Full Information

First Posted
July 13, 2023
Last Updated
July 25, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05973747
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Pregnancy Related, Hypocalcemia, Parturition Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Calcium Gluconate
Arm Type
Experimental
Arm Description
2 grams of calcium gluconate, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping
Arm Title
Calcium Chloride
Arm Type
Active Comparator
Arm Description
0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping
Intervention Type
Drug
Intervention Name(s)
Calcium Gluconate
Intervention Description
2 grams of calcium gluconate, infused intravenously over 10 minutes upon umbilical cord clamping
Intervention Type
Drug
Intervention Name(s)
Calcium chloride
Intervention Description
0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping
Primary Outcome Measure Information:
Title
Serum ionized calcium concentration
Description
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.
Time Frame
Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
Secondary Outcome Measure Information:
Title
Serum pH
Description
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.
Time Frame
Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Parturients all biologically female at birth by necessity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Ansari, MD, MS
Phone
760-845-0328
Email
jansari@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Conti, MD
Phone
805-709-5096
Email
dconti@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Ansari, MD, MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

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