Health Condition 1: E898- Other postprocedural endocrine andmetabolic complications and disorders
Conditions
Interventions
Intervention1: K-Lyte 600 mg Tablet: Dosage must be adjusted to the individual needs of each patient to maintain the potassium level 4.0 to 4.5 mmol/L.
For mild Hypokalemia (3.0 â?? 3.4 mmol/l)
K-Lyt
Sponsors
The ACME LaboratoriesLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ages 18 to 65 years (both gender inclusive) 2. Patient on the investigating unit found mild to moderate serum potassium level. (Mild hypokalemia is a serum level of 3.0 to 3.4 mEq/L, Moderate hypokalemia is a serum level of 2.5-2.9 mEq/L, and severe hypokalemia is a level of less than 2.5 mEq/L.) Ability to take oral tablets. Normal renal function test. Diagnostic Criteria: ï??Diagnosed by physician and concluded the need of electrolyte (potassium) supplementation. ï??Increased potassium loss - Drugs induced hypokalemia: diuretics (thiazides, loop diuretics), laxatives, glucocorticoids, fludrocortisone, penicillins, amphotericin, aminoglycosides etc. - GI losses: diarrhoea, vomiting, ileostomy, intestinal fistula - Renal causes:dialysis - Endocrine disorders: hyperaldosteronism (Connâ??s syndrome), Cushingâ??s syndrome Trans-cellular shift - Insulin/glucose therapy - Salbutamol and other beta-agonists - Theophylline - Metabolic alkalosis Decreased potassium intake Magnesium depletion (associated with increased renal potassium loss) 3. Ethical / legal considerations: All the patients are willing to obtain written informed consent, according to national regulations.
Exclusion criteria
Exclusion criteria: 1. Patients with a serum potassium 3.5 mEq/L. 2. Patients with serum renal dysfunction with urine output 2 mg/dL. 3. Hypomagnesaemia ( 4. Evidence of Intrinsic source of potassium release includes acute rhabdomyolysis, Hemolytic anemia, and tumor lysis. 5. Magnesium level 6. Use of any investigational drug currently or within 30 days prior to study entry. 7. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation. 8. Patients on any prescription medication that might interfere with study outcomes as decided by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adherence to a potassium level 4.0 - 4.5mmol/L 2. Mean changes in serum potassium in mEq/L per each 10 mEq/L of potassium administration. Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total quantity of potassium administered [Time Frame: 7 days] 2. Incidence of potassium level 3.0mmol/L and 5.5mmol/L [Time Frame: 7 days] 3. Tolerance [Visit II â??Visit VII EOT] (Attachment no. 1) 4. Self-Assessment of General Health [Visit II â??Visit VII EOT] (Attachment no. 2) Assessment of safety of investigational product: Timepoint: 7 Days | — |
Countries
India
Contacts
Public ContactDr Harish S
SanjivaniSuperspeciality Hospital Pvt.
Outcome results
None listed