Pharmacodynamics of omeprazole suspension in critically ill pediatric liver/intestinal transplant patients

Kimberly L. Bergman, Stuart Kaufman, Dean S Collier, Jill A. Rebuck, Cindy Brown, Keith Melvin Olsen

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Introduction: Omeprazole is effective in preventing stress-induced gastrointestinal bleeding in the critically ill population, but data regarding its use for prophylaxis with critically ill children are lacking. The purpose of this study was to determine the effect of omeprazole suspension on gastric pH post-operatively in critically ill pediatric liver/intestinal transplant patients and to characterize the pharmacodynamic relationship between first and multiple dose pharmacokinetic parameters and gastric pH. Methods: Ten pediatric liver and/or intestinal transplant patients were administered omeprazole suspension 0.5mg/kg every twelve hours via nasogastric tube within twelve hours of transplantation. Gastric pH was monitored continuously for 48 hours via a calibrated single-channel microetectrode, and sequential initial and multiple dose venous blood samples were obtained. Plasma omeprazole levels will be assayed via high-performance liquid chromatography. Data are expressed as means ± standard deviation. Results: Subject population (age 3.8±4.2 years) consisted of five liver transplants, two small bowel transplants, and three combination liver/small bowel transplants. Baseline pH was 1.0±0.8 upon initial dosing and 7.0± 2.5 prior to the third dose. Onset of action (time to pH greater than 4.0) of omeprazole was 62±84 minutes (range 2 to 226 minutes). Mean pH following the first dose was 6.2±2.1 and following the third dose was 7.6± 1.1. The percentage of the dosage interval for which pH was greater than 4.0 was 81.2±19.1% and 97.8±5.4% with the first and third doses, respectively. One subject experienced gastrointestinal bleeding requiring intervention 40 hours after initiation of omeprazole therapy. Conclusion: Although onset of action of omeprazole suspension was highly variable in this study population, omeprazole adequately maintained baseline and mean gastric pH greater than 4.0 throughout the dosage interval upon multiple doses in this pediatric liver/intestinal transplant population.

Original languageEnglish (US)
JournalCritical care medicine
Volume27
Issue number1 SUPPL.
StatePublished - Dec 1 1999

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Omeprazole
Critical Illness
Suspensions
Pediatrics
Transplants
Liver
Stomach
Population
Hemorrhage
Pharmacokinetics
Transplantation
High Pressure Liquid Chromatography

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

Cite this

Bergman, K. L., Kaufman, S., Collier, D. S., Rebuck, J. A., Brown, C., & Olsen, K. M. (1999). Pharmacodynamics of omeprazole suspension in critically ill pediatric liver/intestinal transplant patients. Critical care medicine, 27(1 SUPPL.).

Pharmacodynamics of omeprazole suspension in critically ill pediatric liver/intestinal transplant patients. / Bergman, Kimberly L.; Kaufman, Stuart; Collier, Dean S; Rebuck, Jill A.; Brown, Cindy; Olsen, Keith Melvin.

In: Critical care medicine, Vol. 27, No. 1 SUPPL., 01.12.1999.

Research output: Contribution to journalArticle

Bergman, Kimberly L. ; Kaufman, Stuart ; Collier, Dean S ; Rebuck, Jill A. ; Brown, Cindy ; Olsen, Keith Melvin. / Pharmacodynamics of omeprazole suspension in critically ill pediatric liver/intestinal transplant patients. In: Critical care medicine. 1999 ; Vol. 27, No. 1 SUPPL.
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title = "Pharmacodynamics of omeprazole suspension in critically ill pediatric liver/intestinal transplant patients",
abstract = "Introduction: Omeprazole is effective in preventing stress-induced gastrointestinal bleeding in the critically ill population, but data regarding its use for prophylaxis with critically ill children are lacking. The purpose of this study was to determine the effect of omeprazole suspension on gastric pH post-operatively in critically ill pediatric liver/intestinal transplant patients and to characterize the pharmacodynamic relationship between first and multiple dose pharmacokinetic parameters and gastric pH. Methods: Ten pediatric liver and/or intestinal transplant patients were administered omeprazole suspension 0.5mg/kg every twelve hours via nasogastric tube within twelve hours of transplantation. Gastric pH was monitored continuously for 48 hours via a calibrated single-channel microetectrode, and sequential initial and multiple dose venous blood samples were obtained. Plasma omeprazole levels will be assayed via high-performance liquid chromatography. Data are expressed as means ± standard deviation. Results: Subject population (age 3.8±4.2 years) consisted of five liver transplants, two small bowel transplants, and three combination liver/small bowel transplants. Baseline pH was 1.0±0.8 upon initial dosing and 7.0± 2.5 prior to the third dose. Onset of action (time to pH greater than 4.0) of omeprazole was 62±84 minutes (range 2 to 226 minutes). Mean pH following the first dose was 6.2±2.1 and following the third dose was 7.6± 1.1. The percentage of the dosage interval for which pH was greater than 4.0 was 81.2±19.1{\%} and 97.8±5.4{\%} with the first and third doses, respectively. One subject experienced gastrointestinal bleeding requiring intervention 40 hours after initiation of omeprazole therapy. Conclusion: Although onset of action of omeprazole suspension was highly variable in this study population, omeprazole adequately maintained baseline and mean gastric pH greater than 4.0 throughout the dosage interval upon multiple doses in this pediatric liver/intestinal transplant population.",
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N2 - Introduction: Omeprazole is effective in preventing stress-induced gastrointestinal bleeding in the critically ill population, but data regarding its use for prophylaxis with critically ill children are lacking. The purpose of this study was to determine the effect of omeprazole suspension on gastric pH post-operatively in critically ill pediatric liver/intestinal transplant patients and to characterize the pharmacodynamic relationship between first and multiple dose pharmacokinetic parameters and gastric pH. Methods: Ten pediatric liver and/or intestinal transplant patients were administered omeprazole suspension 0.5mg/kg every twelve hours via nasogastric tube within twelve hours of transplantation. Gastric pH was monitored continuously for 48 hours via a calibrated single-channel microetectrode, and sequential initial and multiple dose venous blood samples were obtained. Plasma omeprazole levels will be assayed via high-performance liquid chromatography. Data are expressed as means ± standard deviation. Results: Subject population (age 3.8±4.2 years) consisted of five liver transplants, two small bowel transplants, and three combination liver/small bowel transplants. Baseline pH was 1.0±0.8 upon initial dosing and 7.0± 2.5 prior to the third dose. Onset of action (time to pH greater than 4.0) of omeprazole was 62±84 minutes (range 2 to 226 minutes). Mean pH following the first dose was 6.2±2.1 and following the third dose was 7.6± 1.1. The percentage of the dosage interval for which pH was greater than 4.0 was 81.2±19.1% and 97.8±5.4% with the first and third doses, respectively. One subject experienced gastrointestinal bleeding requiring intervention 40 hours after initiation of omeprazole therapy. Conclusion: Although onset of action of omeprazole suspension was highly variable in this study population, omeprazole adequately maintained baseline and mean gastric pH greater than 4.0 throughout the dosage interval upon multiple doses in this pediatric liver/intestinal transplant population.

AB - Introduction: Omeprazole is effective in preventing stress-induced gastrointestinal bleeding in the critically ill population, but data regarding its use for prophylaxis with critically ill children are lacking. The purpose of this study was to determine the effect of omeprazole suspension on gastric pH post-operatively in critically ill pediatric liver/intestinal transplant patients and to characterize the pharmacodynamic relationship between first and multiple dose pharmacokinetic parameters and gastric pH. Methods: Ten pediatric liver and/or intestinal transplant patients were administered omeprazole suspension 0.5mg/kg every twelve hours via nasogastric tube within twelve hours of transplantation. Gastric pH was monitored continuously for 48 hours via a calibrated single-channel microetectrode, and sequential initial and multiple dose venous blood samples were obtained. Plasma omeprazole levels will be assayed via high-performance liquid chromatography. Data are expressed as means ± standard deviation. Results: Subject population (age 3.8±4.2 years) consisted of five liver transplants, two small bowel transplants, and three combination liver/small bowel transplants. Baseline pH was 1.0±0.8 upon initial dosing and 7.0± 2.5 prior to the third dose. Onset of action (time to pH greater than 4.0) of omeprazole was 62±84 minutes (range 2 to 226 minutes). Mean pH following the first dose was 6.2±2.1 and following the third dose was 7.6± 1.1. The percentage of the dosage interval for which pH was greater than 4.0 was 81.2±19.1% and 97.8±5.4% with the first and third doses, respectively. One subject experienced gastrointestinal bleeding requiring intervention 40 hours after initiation of omeprazole therapy. Conclusion: Although onset of action of omeprazole suspension was highly variable in this study population, omeprazole adequately maintained baseline and mean gastric pH greater than 4.0 throughout the dosage interval upon multiple doses in this pediatric liver/intestinal transplant population.

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