Rate of Termination of Premixed Parenteral Nutrition (PN) in Surgical Patients Secondary to High Serum Electrolytes

February 2, 2022 updated by: Hakeam Abdulaziz Hakeam, King Faisal Specialist Hospital & Research Center

Rate of Termination of Commercial Premixed Parenteral Nutrition (PN) in Surgical Patients Secondary to High Serum Electrolyte Levels

Introduction:

Various commercial premixed parenteral nutrition (PN) solutions have been introduced to clinical practice in 3-compartment large volume bags. Olimel N9E is the formulary premixed PN formula at King Faisal Specialist Hospital and Research Centre (KFSH & RC). The commercial premixed PN was associated with a significant cost reduction compared to the compounded PN, with lower incidence of infectious complications, compared to the compounded PN formula. Electrolyte irregularities are commonly encountered with PN use. Patients who develop high serum potassium, magnesium or phosphate levels while receiving premixed PN are shifted to a compounded PN with lower electrolyte content. This study aims to describe the incidence of shifting of premixed PN to a compounded PN secondary to high serum electrolytes in surgical patients receiving commercial premixed PN.

Methods:

This is a prospective, cohort, study, to be conducted at KFSH & RC, Riyadh. This study is proposed to commence after obtaining the approval of the Research Ethical Committee at KFSH & RC. Patients enrolment will start after the approval at KFSH & RC, by data collection phase, that might extend for a suspected 6-month until achieving the target sample size of 55 patients. The analysis phase will follow and elapse for 2 months. This is followed by 2 months to get the initial abstract. All patients will have their potassium, magnesium, calcium and phosphorus levels assessed daily in the morning for the first 7 days of PN initiation. After the first week of PN support, according to the routine laboratories, electrolytes will be assessed at a minimum of three times a week thereafter while on PN. There will be no extra laboratory work obtained for the study purpose. The incidence of shifting from premixed PN to compounded PN will be assessed and reported. A description of the characteristics of patients who develop high serum level of electrolytes will be undertaken using regression analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods Study design and centres This is a prospective, cohort, multi-centre study, to be conducted at King Faisal Specialist Hospital and Research Centre, (KFSH & RC), Riyadh. The study has been approved by KFSH&RC Office of Research Affairs representing the institutional review board (IRB).

Subjects:

Sample Size Sample size has been calculated using Raosoft website based on the total surgical patients who receive PN support on monthly bases, which is 20 patients per month, and the duration of the data collection is expected to elapse 6 months. This makes the field population represented by 120 patients. According to a previous study that assessed need for bolus of electrolytes, 7% of the eligible patients are expected to have the outcome. Allowing for 5% margin of error and 95% confidence level the target sample size will be 72 patients from KFSH&RC. Collaborating centers withdrew from this study due to insufficient eligible patients given the COVID-19 pandemic.

Protocol Surgical patients starting PN will be screened for the inclusion and exclusion criteria by the investigators of the study. Eligible patients will be asked to sign a consent form.

All patients will start PN after normalization of the following electrolytes potassium, magnesium, and phosphorus according to standard. Premixed PN formula, Olimel N9E will be started at a rate of 45 mL per hour for all patients on day 1 of PN support. After the routine assessment by pharmacists, the PN rate will be increased at an increment of 10 mL per hour on daily basis, representing the target goal of protein of 2 gm per kg according to the ideal body weight (IBW) , is achieved. Patients enrolled in the study will be followed while on PN support until cessation of PN or after 30 days of support have elapsed.

All patients will get their potassium, magnesium, and phosphorus levels assessed daily in the morning for the first 7 days of PN initiation. After the first week of PN support, electrolytes will be assessed at a minimum of three times a week thereafter while on PN. High electrolyte levels that develop on the following day of their respective low levels and corrected with bolus will not be considered as induced by PN.

Patients who develop hyperphosphatemia, hypermagnesemia, hyperkalaemia will get their PN stopped immediately and replaced with dextrose 10% water solution to run at 50 mL per hour till 21:00.Premixed PN will commence again at the same rate of the corresponding day. Patients who develop a second episode of any hyperphosphatemia, hypermagnesemia, or hyperkalaemia on the preceding day obtained from a blood sample will be shifted to the compounded PN.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital & Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult (≥ 18) patients admitted to King Faisal Specialist Hospital and Research Centre, Riyadh , under non-cardiac surgical services, whether planned for surgery or to manage a surgical complication that developed within 30 after surgery, in which parenteral nutrition is indicated and is the sole source of nutrition.

Description

Inclusion Criteria:

  • Patients admitted under the care of non-cardiac surgical services, whether planned for surgery or to manage a surgical complications that developed within 30 after surgery.
  • Patients under the care of the following surgical teams: colorectal surgery, oncology surgery, general surgery, and thoracic surgery.
  • Patients starting PN as a sole source for nutrition with feeding status is nil per os (NPO)
  • Patients who receive sips of water or oral tablets will be included in this study.

Exclusion Criteria:

  • Any degree of renal impairment defined as glomerular filtration rate < 60 mL/min/m2 as calculated according to the modification of diet in renal disease (MDRD) equation
  • Morbid obesity defined as body mass index (BMI) of > 40 kg/m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Cohort
Starting premixed Olimel N9E and follow for electrolyte irregularities.
Combination product: Parenteral Nutrition (PN) Premixed Olimel N9E
Parenteral nutrition
Other Names:
  • Olimel N9E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of shifting of Olimel N9E premixed formula to compounded PN secondary to the development of elevated electrolyte levels in surgical patients receiving PN.
Time Frame: Until cessation of parenteral nutritional support or after 30 days of PN support have elapsed.
Serum phosphate level of > 1.45 mmol/L, serum potassium level > 5.0 mmol/L, and serum magnesium level > 1.0 mmol/L.
Until cessation of parenteral nutritional support or after 30 days of PN support have elapsed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of high serum levels of phosphate, magnesium, calcium, and potassium.
Time Frame: Until cessation of parenteral nutritional support or after 30 days of PN support have elapsed
serum phosphate level of > 1.45 mmol/L, serum potassium level > 5.0 mmol/L, and serum magnesium level > 1.0 mmol/L
Until cessation of parenteral nutritional support or after 30 days of PN support have elapsed
Risk factors associated with the development of hyperphosphatemia
Time Frame: Until cessation of parenteral nutritional support or after 30 days of PN support have elapsed
Serum phosphate level of > 1.45 mmol/L
Until cessation of parenteral nutritional support or after 30 days of PN support have elapsed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Faisal Specialist Hospital & Research Center

Investigators

  • Principal Investigator: Hakeam Hakeam, MS Pharm, King Faisal Specialist Hospital and Research Centre (KFSH&RC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2020

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2191316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

On publication, according to the journal requirements.

IPD Sharing Time Frame

After November 2020.

IPD Sharing Access Criteria

Pending

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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