What is the clinical evidence from this study?

Study design: Cross-Sectional. Population: Patients receiving digoxin therapy (n=107). Intervention: Digoxin maintenance therapy vs. Older children and adults. Primary outcome: Mean serum digoxin concentration (p=< .01).

What question did this study set out to answer?

To evaluate serum digoxin levels in infants, children, and adults receiving maintenance therapy and to characterize concentrations associated with digitalis toxicity.

October 1, 1973PEDIATRICS

Serum Digoxin Studies in Infants and Children

Q: What are the key findings of this study?

Nontoxic infants receiving maintenance digoxin therapy had a mean serum concentration of 2.8 ng/ml, significantly higher than the 1.3 ng/ml observed in older children and adults (P < .01).

Q: What question did this study set out to answer?

To evaluate serum digoxin levels in infants, children, and adults receiving maintenance therapy and to characterize concentrations associated with digitalis toxicity.

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Key result

Nontoxic infants on maintenance digoxin show ~115% higher serum levels than older children and adults.

P<.01
n=107

Why the study?

Do serum digoxin levels following standard maintenance therapy differ between infants, children, and adults?

Population

107 patients receiving maintenance digoxin therapy, including 31 nontoxic infants, 33 nontoxic children, 24…

Comparison

Measurement of serum digoxin levels by… vs Comparison across age groups and toxicity status.

Design

Cross-sectional

Follow-up

6 to 24 hours post-dose

Authors

CHConstance J. HayesNewYork–Presbyterian Hospital VBVincent P. ButlerColumbia University WGWelton M. GersonyPediatric / Congenital Cardiology

Discussion

Member takes

Implication

Infant digoxin levels often exceed adult ranges without toxicity; leaves open age-specific therapeutic targets for prospective study.

Key Points

To evaluate serum digoxin levels in infants, children, and adults receiving maintenance therapy and to characterize concentrations associated with digitalis toxicity.
Measured serum digoxin levels using radioimmunoassay 6 to 24 hours after a maintenance dose in 31 infants, 33 children, and 24 adults without toxicity, as well as 19 digitalis-toxic patients.
Evaluated the effects of patient age, route of administration (oral versus intramuscular), and toxicity status on serum drug concentrations.
Mean serum digoxin concentration in nontoxic infants was 2.8 ± 1.9 ng/ml, which was significantly higher than in nontoxic children (1.3 ± 0.4 ng/ml) and adults (1.3 ± 0.6 ng/ml; P < .01).
Sixty-five percent of nontoxic infants had levels exceeding 2.0 ng/ml compared with 18% of nontoxic children.
Mean serum digoxin levels in toxic patients reached 4.4 ng/ml in infants, 3.4 ng/ml in children, and 2.9 ng/ml in adults, with 11 of 15 pediatric toxic cases receiving intramuscular dosing.

Study Design

Type

Cross-Sectional (n=107)

Structured PICO

Do serum digoxin levels following standard maintenance therapy differ between infants, children, and adults?

Population

107 patients, including 31 infants, 33 children, 24 adults, and 19 digitalis-toxic patients, evaluated for serum digoxin levels after receiving a maintenance dose.

Exposure

Measurement of serum digoxin levels by radioimmunoassay 6 to 24 hours after administration of a maintenance dose.

Comparator

Comparison across age groups (infants vs. children vs. adults) and toxicity status (nontoxic vs. toxic).

Outcome

Mean serum digoxin concentration.surrogate

Main Result

Absolute Event Rate: 2.8% vs 1.3%

p-value: p=< .01

Infants receiving standard maintenance digoxin therapy have significantly higher serum digoxin levels than older children and adults, often reaching ranges considered toxic in adults.

Cite This Study

Hayes et al. (1973) conducted a cross-sectional in Patients receiving digoxin therapy (n=107). Digoxin maintenance therapy vs. Older children and adults was evaluated on Mean serum digoxin concentration (p=< .01). Nontoxic infants receiving maintenance digoxin therapy had a mean serum concentration of 2.8 ng/ml, significantly higher than the 1.3 ng/ml observed in older children and adults (P < .01).

synapsesocial.com/papers/6aa3ae36e0a56e090ff42e97 https://doi.org/10.1542/peds.52.4.561

Topics

Congenital heart disease adults

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Serum Digoxin Studies in Infants and Children

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Serum Digoxin Studies in Infants and Children

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

Also Consider