Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant female subjects delivering at the study institution via scheduled cesarean delivery at term (>=37 weeks gestation)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Calcium Gluconate (Drug)
Calcium Chloride
0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping
干预措施: Calcium chloride (Drug)
结局指标
主要结局
Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g)
时间窗: 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
Clearance from first to second compartment (L/min)
时间窗: 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
Volume of distribution of first compartment of pharmacokinetic model (L)
时间窗: 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
Clearance from second compartment (L/min)
时间窗: 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
Volume of distribution of second compartment of pharmacokinetic model (L)
时间窗: 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
次要结局
- Serum pH(Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion)
- Baseline serum ionized calcium concentration(Baseline prior to calcium infusion)
- Peak change in serum ionized calcium concentration (mmol/L)(Measured immediately at completion of the 10-minute calcium infusion.)
- Time to half of peak change in ionized calcium (minutes)(10-60 minutes after infusion initiation)
研究者
Jessica Ansari, MD
Clinical Assistant Professor of Anesthesiology
Stanford University