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Study Title and Description

Another case of excessive caffeine and hypokalemia 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 Another case of excessive caffeine and hypokalemia in pregnancy.
Author SL Young,ML Hage,J Li,
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
No arms have been defined in this extraction form.

Design Details
Question... Follow Up Answer Follow-up Answer
Refid 11704186
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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)? This was actually a letter to the editor but it contains new data - they submit the same sort of data the was present in a case report. authors state: report our experience in treating a patient with caffeine induced hypokalemic paralysis in pregnancy
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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) took medical history: 38.5 weeks gestation, weakness and muscle aches, took medical and family history. Self reported intake documented by authors as 8-9 servings/day of caffeinated cola or ice tea in 12-16 oz cups. Only prenatal vitamins. Standard lab data presented (urine/blood work)
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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) hypokalemia
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes I said one b/c this is focused on hypokalemia but they look at a full blood batter/urine battery, briefly mention dehydration and briefly discuss paralysis both considered secondary to the hypokalemia
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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? Both
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Optional: Name of Method or short description Blood work done, potassium measured, but note of extent of and improved paralysis was subjective
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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 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
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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
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Provide a general description of results (as reported by the authors). By hospital day 4 the patient had received approximately 400 mmol of potassium, and her serum potassium level was normal at 4.5 mmol/L. Creatinine phosphokinase level was decreasing. She was discharged without potassium supplementation and was instructed to abstain from all caffeinated products.
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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? Resolution of hypokalemia with restriction of caffeine intake suggests that this was a case of caffeine-induced hypokalemia in pregnancy
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What were the sources of funding? none
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What conflicts of interest were reported? none
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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). soda (12-16oz/serving)(8-9 serving/day)(3mg caffeine/oz) = 288-432mg tea (12-16oz/serving)(8-9 serving/day)(5.9mg caffeine/oz) = 566.4 - 849.6
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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.  LOAEL = 288-849.6mg, hypokalemia induced paralysis in pregnant woman
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. * they listed a range which I converted so this LOAEL is actually somewhere between 288-849.6mg based on self reporting
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What is the importance of the study with respect to the adverseness of the outcome? Low
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