CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Parenteral Nutrition (PN) Premixed Olimel N9Ecombination
Likely dose
Not stated in record
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Search/NCT04256369
NCT04256369N/ACompleted

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

King Faisal Specialist Hospital & Research Center·observational·Posted Feb 5, 2020·Updated Feb 3, 2022

In Brief

An observational study evaluating Parenteral Nutrition (PN) Premixed Olimel N9E for Hyperphosphatemia and 3 related conditions. Completed, enrolled 72 participants across 1 site.

Detailed Summary

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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 5, 2020
Enrollment StartFeb 2, 2020
Primary CompletionDec 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.4 years ago

Interventions

Parenteral Nutrition (PN) Premixed Olimel N9Ecombination

Parenteral nutrition