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Acute Hypokalemia | Comparison of Enteral Versus Intravenous Potassium Supplementation

Acute Hypokalemia research study

What is the primary objective of this study?

Null hypothesis: There is no difference in the efficacy of IVPR and EPR during an episode of hypokalemia. Alternate Hypothesis: There is a mean difference of 15% in Serum Potassium levels between the two groups. Objective: To compare the efficacy EPR and IVPR for treatment of hypokalemia (measured as change in serum potassium levels in milliequivalent/L after potassium replacement)

Who is eligible to participate?

Inclusion Criteria: - • All patients undergoing surgical repair/palliation of congenital heart lesion at the Aga Khan University Hospital and admitted to the pediatric cardiac intensive care unit (PCICU) for post-operative management. - Serum potassium levels (<4.39 meq/l) immediate post operatively - Patients/parents willing to participate in the study - Have a central venous line for IVPR and an arterial line for monitoring and blood draws. - Able to tolerate oral or nasogastric administration of medication for EPR. Exclusion Criteria: - • Patients with acute renal failure (estimated clearance creatinine - eccr <50) - Patients with paralytic ileus, necrotizing enterocolitis or GI bleeding. - Patients with nausea, vomiting or diarrhea prior to randomization. Patients will not be excluded if these symptoms develop during the trial after the initial recruitment. Based on clinical decision the route of potassium supplementation may be changed if these symptoms. Intention to treat analysis will be used for the primary end point. - Patient with symptomatic hypokalemia (manifested as a rhythm disturbances). - Initial serum K level (post surgery) < 2.0 mEq

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Hypokalemia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Intravenous potassium chloride

Drug:Oral potassium chloride

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Intravenous potassiumPatients in this arm will be administered intravenous potassium if they develop hypokalemia. As per CICU protocol 1-ml blood sample from already placed art-line or central venous line is sent for analysis of serum potassium concentration in all the immediate post operative patients. In the IVPR group, potassium will be given according to the hospital protocol through a central line. As per a previously established protocol and bioavailability data, repeat serum potassium will be sent 1 hour after replacement in the IVPR group.

Enteral potassium (ERP)Once included in the study, patients in this arm will be given oral potassium if they develop an episode of hypokalemia. As per CICU protocol 1-ml blood sample from already placed art-line or central venous line is sent for analysis of serum potassium concentration in all the immediate post operative patients. As per a previously established protocol and bioavailability data, repeat serum potassium will be sent 2 hours after replacement in the EPR group. Replacement and serum level monitoring will be done till the episode of hypokalemia is resolved

Study Status

Unknown status

Start Date: October 2013

Completed Date: May 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: The efficacy EPR and IVPR for treatment of hypokalemia (measured as change in serum potassium levels in milliequivalent/liter (mEq/L) after potassium replacement

Secondary Outcome: Comparison of adverse effects after EPR and IVPR.

Study sponsors, principal investigator, and references

Principal Investigator: Anwarul Haq, MD

Lead Sponsor: Aga Khan University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02015962

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