Comparison of Enteral Versus Intravenous Potassium Supplementation

NCT ID: NCT02015962

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-05-31

Brief Summary

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)

Detailed Description

Hypokalemia is frequently encountered in daily clinical practices of cardiac intensive care unit (CICU). The development of ventricular arrhythmias related to hypokalemia can lead to sudden cardiac death. Thus, potassium replacement therapy is the cornerstone therapy for hypokalemia.Though intravenous potassium replacement (IVPR) in hypokalemia is the preferred route in most intensive care settings, it is associated with known safety risks. Inappropriately administered, IVPR can lead to arrhythmias, cardiac arrest and death 1, 7, 8. Given these risks, IVPR is considered a "high-alert medication" by Institute of Safe Medication practice.

Enteral potassium replacement (EPR), with its superior safety profile may be a better alternative to IVPR. A retrospective review showed that the efficacy of EPR was comparable to IVPR in pediatric patients after congenital heart disease.

The investigators seek to explore this comparison between EPR and IVPR in a randomized prospective trial

Conditions

Acute Hypokalemia

Keywords

Hypokalemia; Intravenous; Enteral; post-cardiac surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous potassium

Patients 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.

Group Type: EXPERIMENTAL

Intravenous potassium chloride

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Oral potassium chloride

Intervention Type: DRUG

Interventions

Intravenous potassium chloride

Intervention Type: DRUG

Oral potassium chloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr Babar S Hasan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anwarul Haq, MD

Role: STUDY_DIRECTOR

Aga Khan University

Locations

CICU- Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status: RECRUITING

The Aga Khan University

Karachi, Sindh, Pakistan

Site Status: RECRUITING

The Aga Khan University

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Anwar Ul Haque, MD

Role: CONTACT

Phone: 922134864791

Email: anwar.haq@aku.edu

Babar S Hasan, MD

Role: CONTACT

Phone: 922134864364

Email: babar.hasan@aku.edu

Facility Contacts

Ashar Ali

Role: primary

Asghar Ali

Role: primary

Asghar Ali

Role: primary

References

Rehman Siddiqu NU, Merchant Q, Hasan BS, Rizvi A, Amanullah M, Rehmat A, Ul Haq A. Comparison of enteral versus intravenous potassium supplementation in hypokalaemia in paediatric patients in intensive care post cardiac surgery: open-label randomised equivalence trial (EIPS). BMJ Open. 2017 May 10;7(5):e011179. doi: 10.1136/bmjopen-2016-011179.

Reference Type: DERIVED

PMID: 28495809 (View on PubMed)

Merchant Q, Rehman Siddiqui NU, Rehmat A, Amanullah M, Haq AU, Hasan B. Comparison of Enteral versus Intravenous Potassium Supplementation in hypokalaemia in postcardiac surgery paediatric cardiac intensive care patients: prospective open label randomised control trial (EIPS). BMJ Open. 2014 Sep 4;4(9):e005124. doi: 10.1136/bmjopen-2014-005124.

Reference Type: DERIVED

PMID: 25190615 (View on PubMed)

Other Identifiers

EIPS

Identifier Type: -

Identifier Source: org_study_id