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Study Title and Description

Caffeine-induced hypokalemic paralysis in pregnancy.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on acute toxicity*?
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Primary Publication Information
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TitleData
Title Caffeine-induced hypokalemic paralysis in pregnancy.
Author CC Appel,TD Myles,
Country
Year 2001
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Acute Toxicity - Study Design Details
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 11336759
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What outcome is being evaluated in this paper? Acute
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What is the objective of the study (as reported by the authors)? To report a case of excessive ingestion of caffeine whereby caffeine can induce hypokalemia, which affects the neuromuscular system and can lead to paralysis
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) 24 year old Hispanic woman admitted to hospital with muscular paralysis and hypokalemia secondary to drinking 6-7 L of cola per day with little other oral intake. laboratory tests were run and urinary endpoints evaluated as well as lumbar puncture, ECG, pulmonary function and electromyography. Additionally an ultrasound for the baby. Caffeine was self reported as 5-44oz cola's per day , authors interpreted this to be 900mg/day and very low food intake
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How many outcome-specific endpoints are evaluated? 1
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) blood work (potassium, creatinine phosphokinase, myoglobin)
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes I wasn't sure how to count this - they did standard blood work up, urine, muscle, heart and checked on baby
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Clinical Clinical
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Physiological
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Other
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What is the study design? Case report
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Randomized or Non-Randomized?
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What were the diagnostics or methods used to measure the outcome? Objective
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Optional: Name of Method or short description laboratory analysis conducted in a hospital setting as patient was admitted (assume standard hospital battery)
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Caffeine (general)
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Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda Soda
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Tea
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Measured
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Self-report Self-report
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Children
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Adolescents
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Adults
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Pregnant Women Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) none, 2 other cases found in the literature were briefly discussed
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) none directly called out- although other syndromes were ruled out that could lead to predisposition to low potassium (Bartter syndrome, Conn syndrome), also ruled out laxative abuse.
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Provide a general description of results (as reported by the authors). This is reported as a "comment" not a conclusion. Renal loss of potassium appeared to be the primary cause of hypokalemia, patient was normotensive with renin levels four times normal in pregnancy. potassium was corrected with potassium chloride, caffeine containing beverages were withheld and serum potassium normalized by day 3 and by 5th hospital day she was fully ambulatory
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Did the authors perform a dose-response analysis (or trend/related analysis)? No
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What were the authors's observations re: trend analysis?
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What were the author's conclusions? The physiologic changes of pregnancy might potentiate the effect of caffeine on serum potassium concentration. This case illustrates the importance of obtaining a history of caffeine intake in patients with hypokalemic paralysis and the importance of dietary counseling in pregnant women
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What were the sources of funding? none reported
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What conflicts of interest were reported? none reported
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Does the exposure (dose) need to be standardized to the SR? Yes
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest). they report 900 mg/day; they discuss 5-44 oz cans consumed per day= 220oz.
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  hypokalemia (900mg) according to authors if we standardize using our values this would be 660mg
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. acute toxicity
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What is the importance of the study with respect to the adverseness of the outcome? Low
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Baseline Characteristics
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Results & Comparisons

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Adverse Events
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