Trial record 3 of 44 for:    Open Studies | "Potassium"

Comparison of Enteral Versus Intravenous Potassium Supplementation (EIPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Aga Khan University
Sponsor:
Information provided by (Responsible Party):
Dr Babar S Hasan, Aga Khan University
ClinicalTrials.gov Identifier:
NCT02015962
First received: November 20, 2013
Last updated: December 14, 2013
Last verified: December 2013
  Purpose

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)


Condition Intervention Phase
Acute Hypokalemia
Drug: Intravenous potassium chloride
Drug: Oral potassium chloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Enteral Versus Intravenous Potassium Supplementation in Hypokalemia in Post Cardiac Surgery Pediatric Cardiac Intensive Care Patients - Prospective Open Label Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • The efficacy EPR and IVPR for treatment of hypokalemia (measured as change in serum potassium levels in milliequivalent/liter (mEq/L) after potassium replacement [ Time Frame: The primary endpoint will be assessed every 1 hour in the IVPR group and every 2 hour in the EPR group after replacement of potassium. The patients will be followed for the duration of CICU stay which will be around 1 week. ] [ Designated as safety issue: No ]

    The intervention arms will be blocked randomized as alternate week for I/V and enteral potassium replacement for trial's operational feasibility. Recruited patients will receive treatment accordingly.

    In case where a patient develops side effects such as diarrhea or vomiting, even though he will be changed to IV route of potassium supplement, he will be considered enteral supplementation during data analysis till the point when the patient had received enteral replacement.

    In the IVPR group, potassium will be given according to the hospital protocol through a central line. As per a previously established protocol, repeat serum potassium will be sent 1 hour after replacement in the IVPR group and 2 hours after replacement in the EPR group. Replacement and serum level monitoring will be done till the episode of hypokalemia is resolved.



Secondary Outcome Measures:
  • Comparison of adverse effects after EPR and IVPR. [ Time Frame: Adverse events will be monitored every 2 hours after potassium supplementation. The patients will be followed for the duration of CICU stay which will be around 1 week. ] [ Designated as safety issue: Yes ]
    Adverse effects that will be monitored are hyperkalemia (defined as potassium levels > 5 mEq/L, arrhythmias (defined as any rhythm other than sinus during or within 2 hours of potassium replacement), diarrhea (described as > 2 loose stools or a single watery stool, during or within 2 hours of potassium replacement , GI bleeds, nausea and vomiting (during or within 2 hours of potassium replacement). These adverse events will be monitored on hourly bases by the CICU nursing staff as per CICU protocol. These adverse events will be documented on the CICU nursing sheet (as per routine) and the data gathered every morning by the principal or co-investigators. The on-call physician will be contacted, as per routine, by the nursing to determine any change in mode/dose of potassium replacement if adverse events occur. The on-call physician will in-turn contact either the principal or one of the co-investigators to further discuss the plan.

  • Comparison of number of dose/s required to achieve resolution of hypokalemia [ Time Frame: Dose administration(one hour after IV and two hours after enteral) will be continued till the episode of hypokalemia resolves. Each episode will last ~ 5 hours. The patients will be followed for the duration of CICU stay which will be around 1 week. ] [ Designated as safety issue: No ]
  • Efficacy of EPR and IVPR for various degrees of severity of hypokalemia for each episode of hypokalemia [ Time Frame: An episode of hypokalemia would last ~ 5 hours. The patients will be followed for the duration of CICU stay which will be around 1 week. ] [ Designated as safety issue: No ]
    Degree of severity: Mild, moderate or severe as determined by the protocol.


Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Intravenous potassium chloride
Experimental: 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
Drug: Oral potassium chloride

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

  Eligibility

Ages Eligible for Study:   up to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015962

Contacts
Contact: Anwar Ul Haque, MD 922134864791 anwar.haq@aku.edu
Contact: Babar S Hasan, MD 922134864364 babar.hasan@aku.edu

Locations
Pakistan
CICU- Aga Khan University Hospital Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Ashar Ali    (92)(21)3 4864385    asghar.ali@aku.edu   
Sub-Investigator: Babar Hasan, MD         
Principal Investigator: Anwarul Haque, MD         
The Aga Khan University Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Asghar Ali    (92)(21)3 4864385    asghar.ali@aku.edu   
Sub-Investigator: Babar S Hasan, MD         
Principal Investigator: Anwarul Haque, MD         
The Aga Khan University Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Asghar Ali    92 213 4864385    asghar.ali@aku.edu   
Principal Investigator: Anwarul Haque, MD         
Sub-Investigator: Babar S Hasan, MD         
Sponsors and Collaborators
Aga Khan University
Investigators
Study Director: Anwarul Haq, MD The Aga Khan University
  More Information

No publications provided

Responsible Party: Dr Babar S Hasan, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT02015962     History of Changes
Other Study ID Numbers: EIPS
Study First Received: November 20, 2013
Last Updated: December 14, 2013
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
Hypokalemia
Intravenous
Enteral
post-cardiac surgery

Additional relevant MeSH terms:
Hypokalemia
Potassium Deficiency
Water-Electrolyte Imbalance
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 20, 2014