Acute HypokalemiaPhase 4EIPSNCT02015962
Comparison of Enteral Versus Intravenous Potassium Supplementation
A Phase 4 study testing Intravenous potassium chloride and Oral potassium chloride in people with Acute Hypokalemia, run by Aga Khan University at 3 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 25 years
- Conditions the study is for
- Acute Hypokalemia
- What is being tested?
- Intravenous potassium chloride and Oral potassium chloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesPakistan
- Study dates
- Oct 2013to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • 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.
Who cannot join
- • 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
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites, 3 recruiting
- Recruiting
CICU- Aga Khan University Hospital
Karachi, Sindh, 74800
Ashar Ali, (92)(21)3 4864385, asghar.ali@aku.edu
Babar Hasan, MD
- Recruiting
The Aga Khan University
Karachi, Sindh, 74800
Asghar Ali, (92)(21)3 4864385, asghar.ali@aku.edu
Babar S Hasan, MD
- Recruiting
The Aga Khan University
Karachi, Sindh, 74800
Asghar Ali, 92 213 4864385, asghar.ali@aku.edu
Anwarul Haque, MD
About this study
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
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)
Read the 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
- Being tested
- Intravenous potassium chloride, Oral potassium chloride
- Keywords
- Hypokalemia, Intravenous, Enteral, post-cardiac surgery
- Medical subject headings
- Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous potassium chlorideDrug
Oral potassium chlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous potassium | Experimental | 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. Receives: Drug: Intravenous potassium chloride |
| Enteral potassium (ERP) | Experimental | 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 Receives: Drug: Oral potassium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (3)
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.
Measured: 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.
Comparison of number of dose/s required to achieve resolution of hypokalemia
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute HypokalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Babar S Hasan, Aga Khan University
- Investigators
- Anwarul Haq, MD, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015962
- Sponsor's protocol ID
- EIPS
- Acronym
- EIPS
- Status last verified
- Dec 2013
- First submitted
- 20 Nov 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28495809Merchant 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.
PubMed 25190615
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02015962
- Acronym / sponsor ID
- EIPS / EIPS
- Conditions
- Acute Hypokalemia
- Keywords
- Hypokalemia, Intravenous, Enteral, post-cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous potassium | Experimental | Drug: Intravenous potassium chloridePatients 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) | Experimental | Drug: Oral potassium chlorideOnce 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 |
Who may qualify
- Ages
- 1 day to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- • 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.
Key exclusion criteria (5 listed)
- • Patients with acute renal failure (estimated clearance creatinine - eccr <50)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous potassium chloride | Drug | Intravenous potassium |
| Oral potassium chloride | Drug | Enteral potassium (ERP) |
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
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Derived from this study: PubMed 28495809Rehman 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.
- Derived from this study: PubMed 25190615Merchant 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anwarul Haq, MD study director
Aga Khan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous potassium chloride and Oral potassium chloride in people with Acute Hypokalemia, run by Aga Khan University at 3 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anwar Ul Haque, MD (922134864791, anwar.haq@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015962, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.