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Comparison of Enteral Versus Intravenous Potassium Supplementation (EIPS)

Primary Purpose

Acute Hypokalemia

Status
Unknown status
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Intravenous potassium chloride
Oral potassium chloride
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypokalemia focused on measuring Hypokalemia, Intravenous, Enteral, post-cardiac surgery

Eligibility Criteria

1 Day - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CICU- Aga Khan University HospitalRecruiting
  • The Aga Khan UniversityRecruiting
  • The Aga Khan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intravenous potassium

Enteral potassium (ERP)

Arm Description

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.

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

Outcomes

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
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.
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
Efficacy of EPR and IVPR for various degrees of severity of hypokalemia for each episode of hypokalemia
Degree of severity: Mild, moderate or severe as determined by the protocol.

Full Information

First Posted
November 20, 2013
Last Updated
December 14, 2013
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT02015962
Brief Title
Comparison of Enteral Versus Intravenous Potassium Supplementation
Acronym
EIPS
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypokalemia
Keywords
Hypokalemia, Intravenous, Enteral, post-cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous potassium
Arm Type
Experimental
Arm Description
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.
Arm Title
Enteral potassium (ERP)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Intravenous potassium chloride
Intervention Type
Drug
Intervention Name(s)
Oral potassium chloride
Primary Outcome Measure Information:
Title
The efficacy EPR and IVPR for treatment of hypokalemia (measured as change in serum potassium levels in milliequivalent/liter (mEq/L) after potassium replacement
Description
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.
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.
Secondary Outcome Measure Information:
Title
Comparison of adverse effects after EPR and IVPR.
Description
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.
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.
Title
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.
Title
Efficacy of EPR and IVPR for various degrees of severity of hypokalemia for each episode of hypokalemia
Description
Degree of severity: Mild, moderate or severe as determined by the protocol.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anwar Ul Haque, MD
Phone
922134864791
Email
anwar.haq@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Babar S Hasan, MD
Phone
922134864364
Email
babar.hasan@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anwarul Haq, MD
Organizational Affiliation
The Aga Khan University
Official's Role
Study Director
Facility Information:
Facility Name
CICU- Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashar Ali
Phone
(92)(21)3 4864385
Email
asghar.ali@aku.edu
First Name & Middle Initial & Last Name & Degree
Babar Hasan, MD
First Name & Middle Initial & Last Name & Degree
Anwarul Haque, MD
Facility Name
The Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asghar Ali
Phone
(92)(21)3 4864385
Email
asghar.ali@aku.edu
First Name & Middle Initial & Last Name & Degree
Babar S Hasan, MD
First Name & Middle Initial & Last Name & Degree
Anwarul Haque, MD
Facility Name
The Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asghar Ali
Phone
92 213 4864385
Email
asghar.ali@aku.edu
First Name & Middle Initial & Last Name & Degree
Anwarul Haque, MD
First Name & Middle Initial & Last Name & Degree
Babar S Hasan, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28495809
Citation
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.
Results Reference
derived
PubMed Identifier
25190615
Citation
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.
Results Reference
derived

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Comparison of Enteral Versus Intravenous Potassium Supplementation

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