PMID- 12873922
OWN - NLM
STAT- MEDLINE
DCOM- 20030822
LR  - 20210902
IS  - 0003-2999 (Print)
IS  - 0003-2999 (Linking)
VI  - 97
IP  - 2
DP  - 2003 Aug
TI  - Adverse events after protamine administration following cardiopulmonary bypass in 
      infants and children.
PG  - 383-389
LID - 10.1213/01.ANE.0000072545.13681.FA [doi]
AB  - We performed this study to determine the incidence of and risk factors for 
      adverse events (AEs) in infants and children after the IV administration of 
      protamine after cardiopulmonary bypass. In a retrospective cohort study, all 
      relevant anesthesia records from a 3-yr period were examined to identify AEs 
      after protamine. The AEs were then grouped into three categories by applying 
      increasingly strict criteria. Among 1249 anesthesia records, there were no 
      documented episodes of isolated or hypotension-associated right-sided cardiac 
      failure or acute pulmonary dysfunction. The incidence of systemic hypotension 
      after protamine was between 1.76% (95% confidence interval [CI], 1.11%-2.65%) and 
      2.88% (95% CI, 2.03%-3.97%), depending on the strictness of case definition. To 
      identify risk factors, we performed a nested case-control study in which 
      unmatched controls were randomly selected from the parent cohort at a 4:1 ratio 
      to cases. Cases of hypotension after protamine were more likely during operations 
      on girls (odds ratio [OR], 6.47; 95% CI, 1.66-32.8), after larger doses of 
      protamine (OR, 1.88; 95% CI, 1.03-3.63), or after smaller doses of heparin (OR, 
      0.49; 95% CI, 0.17-0.67). IMPLICATIONS: Systemic hypotension after protamine 
      administration occurred in 1.76%-2.88% of pediatric patients having cardiac 
      surgery. Female sex, larger protamine dose, and smaller heparin dose were each 
      associated with increased risk. The development of protamine alternatives or 
      prophylactic therapies may be useful for reducing the frequency of these events.
FAU - Seifert, Harry A
AU  - Seifert HA
AD  - *Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics 
      and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, 
      Pennsylvania; and daggerDivision of Cardiothoracic Anesthesiology, Department of 
      Anesthesiology & Critical Care, The Children's Hospital of Philadelphia, 
      University of Pennsylvania, Philadelphia, Pennsylvania.
FAU - Jobes, David R
AU  - Jobes DR
FAU - Ten Have, Thomas
AU  - Ten Have T
FAU - Kimmel, Stephen E
AU  - Kimmel SE
FAU - Montenegro, Lisa M
AU  - Montenegro LM
FAU - Steven, James M
AU  - Steven JM
FAU - Nicolson, Susan C
AU  - Nicolson SC
FAU - Strom, Brian L
AU  - Strom BL
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Anesth Analg
JT  - Anesthesia and analgesia
JID - 1310650
RN  - 0 (Heparin Antagonists)
RN  - 0 (Protamines)
SB  - IM
MH  - Adolescent
MH  - *Cardiopulmonary Bypass
MH  - Case-Control Studies
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Heparin Antagonists/*adverse effects
MH  - Humans
MH  - Hypotension/chemically induced
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Multivariate Analysis
MH  - Odds Ratio
MH  - Protamines/*adverse effects
MH  - Retrospective Studies
MH  - Risk Factors
EDAT- 2003/07/23 05:00
MHDA- 2003/08/23 05:00
CRDT- 2003/07/23 05:00
PHST- 2003/07/23 05:00 [pubmed]
PHST- 2003/08/23 05:00 [medline]
PHST- 2003/07/23 05:00 [entrez]
AID - 00000539-200308000-00015 [pii]
AID - 10.1213/01.ANE.0000072545.13681.FA [doi]
PST - ppublish
SO  - Anesth Analg. 2003 Aug;97(2):383-389. doi: 10.1213/01.ANE.0000072545.13681.FA.