[c09aa8]: / clusters / 9knumclustersv2 / clust_2980.txt

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Documented within days of registration: Sodium: >= and =< mmol/L
The following metabolic values will exclude patients from study enrollment: \r\n* Serum calcium (ionized or adjusted for albumin) < mg/dl (. mmol/L) or > . mg/dl (> . mmol/L) despite intervention to normalize levels\r\n* Magnesium < . mg/dl (< . mmol/L) or > mg/dl (> . mmol/L) despite intervention to normalize levels; Note: patients with an initial magnesium < . mmol/L (. mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigators discretion\r\n* Potassium < . mmol/L or > mmol/L despite intervention to normalize levels\r\n* Sodium < mmol/L or > mmol/L despite intervention to normalize levels
Significant electrolyte imbalance prior to enrollment (note that patients may be supplemented to achieve acceptable electrolyte values):\r\n* Hypomagnesemia < . mg/dL or . mmol/L\r\n* Hypocalcemia < . mg/dL or . mmol/L\r\n* Hypokalemia < . mmol/L
Lactic acid levels > mmol/L and/or serum pH < . at screening.
Grade - electrolyte abnormalities (CTCAE v .) except sodium, which must be ? mmol/L.
Lactate levels > mmol/L and or and serum pH < . at screening
Significant electrolyte imbalance prior to enrollment (note that patients may be supplemented to achieve acceptable electrolyte values):\r\n* Hypomagnesemia < . mg/dL or . mmol/L\r\n* Hypokalemia < . mmol/L
Serum calcium (ionized or adjusted for albumin) < mg/dl (. mmol/L) or > . mg/dl (> . mmol/L) despite intervention to normalize levels
Magnesium < . mg/dl (< . mmol/L) or > mg/dl (> . mmol/L) despite intervention to normalize levels
Potassium < . mmol/L or > mmol/L despite intervention to normalize levels
Chloride - mmol/L
Serum calcium (ionized or adjusted for albumin) < mg/dl (. mmol/L) or > . mg/dl (> . mmol/L) despite intervention to normalize levels
Glucose < mg/dl (< . mmol/L) or > mg/dl (> mmol/L)
Magnesium < . mg/dl (< . mmol/L) or > mg/dl (> . mmol/L) despite intervention to normalize levels
Potassium < . mmol/L or > mmol/L despite intervention to normalize levels
Sodium < mmol/L or > mmol/L despite intervention to normalize levels
Serum calcium (ionized or adjusted for albumin) < mg/dl (. mmol/L) or > . mg/dl (> . mmol/L) despite intervention to normalize levels
Glucose < mg/dl (< . mmol/L) or > mg/dl (> mmol/L)
Magnesium < . mg/dl (< . mmol/L) or > mg/dl (> . mmol/L) despite intervention to normalize levels
Potassium < . mmol/L or > mmol/L despite intervention to normalize levels
Sodium < mmol/L or > mmol/L despite intervention to normalize levels
Grade - electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v]. ):\r\n* Serum calcium (ionized or adjusted for albumin) < mg/dl (. mmol/L) or > . mg/dl\r\n(> . mmol/L) despite intervention to normalize levels\r\n* Magnesium < . mg/dl (< . mmol/L) or > mg/dl (> . mmol/L) despite intervention to normalize levels\r\n* Potassium < . mmol/L or > mmol/L despite intervention to normalize levels\r\n* Sodium < mmol/L or > mmol/L despite intervention to normalize levels
Significant electrolyte imbalance prior to enrollment:\r\n* Hypomagnesemia < . mg/dL or . mmol/L\r\n* Hypocalcemia < . mg/dL or . mmol/L\r\n* Hypokalemia < . mmol/L
Patients with hyponatremia (sodium < mmol/L)
Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within months prior to registration\r\n* Transmural myocardial infarction within months prior to registration\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within year prior to registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients\r\n* Grade - electrolyte abnormalities (CTCAE, v. ):\r\n** Serum calcium (ionized or adjusted for albumin) < mg/dl (. mmol/L) or > . mg/dl (> . mmol/L) despite intervention to normalize levels\r\n** Glucose < mg/dl (< . mmol/L) or > mg/dl (> mmol/L)\r\n** Magnesium < . mg/dl (< . mmol/L) or > mg/dl (> . mmol/L) despite intervention to normalize levels\r\n** Potassium < . mmol/L or > mmol/L despite intervention to normalize levels\r\n** Sodium < mmol/L or > mmol/L despite intervention to normalize levels
CTCAE version (v). grade - electrolyte abnormalities:\r\n* Calcium < mg/dl or > . mg/dl;\r\n* Glucose < mg/dl or > mg/dl;\r\n* Magnesium < . mg/dl or > mg/dl;\r\n* Potassium < mmol/L or > mmol/L;\r\n* Sodium < mmol/L or > mmol/L
Grade ? hypercholesterolemia (TC > mg/dL or >. mmol/L) and/or hypertriglyceridemia (TG > mg/dL or >. mmol/L) in the fasting state.
Significant electrolyte imbalance prior to enrollment (note that patients may be supplemented to achieve acceptable electrolyte values):\r\n* Hypomagnesemia < . mg/dL or . mmol/L\r\n* Hypocalcemia < . mg/dL or . mmol/L\r\n* Hypokalemia < . mmol/L
Serum phosphate levels >= . mg/dL or >= . mmol/L
Serum sodium level is ? mmol/L
Serum sodium level ? mmol/L
Serum sodium greater than mmol/L
Magnesium >= .mg/dL or . mmol/L
. mmol/L]).
Serum sodium level is ? mmol/L
Sodium - mmol/L (inclusive)
Hyponatremia (sodium < mmol/L)