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*?|
Primary Publication Information
|Title||Another case of excessive caffeine and hypokalemia in pregnancy.|
|Author||SL Young,ML Hage,J Li,|
Secondary Publication Information
There are currently no secondary publications defined for this study.
Extraction Form: Acute Toxicity - Study Design Details
No arms have been defined in this extraction form.
|Question... Follow Up||Answer||Follow-up Answer|
|What outcome is being evaluated in this paper?||Acute|
|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|
|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)|
|How many outcome-specific endpoints are evaluated?||1|
|What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately)||hypokalemia|
|List additional health endpoints (separately).|
|List additional health endpoints (separately)|
|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|
|What is the study design?||Case report|
|Randomized or Non-Randomized?|
|What were the diagnostics or methods used to measure the outcome?||Both|
|Optional: Name of Method or short description||Blood work done, potassium measured, but note of extent of and improved paralysis was subjective|
|Pregnant Women||Pregnant Women|
|What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.)||none|
|What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models. Copy from methods)||none|
|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.|
|Did the authors perform a dose-response analysis (or trend/related analysis)?||No|
|What were the authors's observations re: trend analysis?|
|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|
|What were the sources of funding?||none|
|What conflicts of interest were reported?||none|
|Does the exposure (dose) need to be standardized to the SR?||Yes|
|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|
|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|
|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|
|What is the importance of the study with respect to the adverseness of the outcome?||Low|
No baseline characteristics have been defined for this extraction form.
Results & Comparisons
No Results found.
|Arm or Total||Title||Description||Comments|
No quality dimensions were specified.
No quality rating data was found.