HyperphosphatemiaNCT04256369
Rate of Termination of Premixed Parenteral Nutrition (PN) in Surgical Patients Secondary to High Serum Electrolytes
An observational study of Hyperphosphatemia and Hyperkalemia, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia, Hyperkalemia, Hypermagnesemia
- What is being tested?
- Parenteral Nutrition (PN) Premixed Olimel N9E
- How many people
- 72 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Feb 2020to 30 Dec 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Centre
Riyadh, 11211
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Hyperphosphatemia, Hyperkalemia, Hypermagnesemia, Hypercalcemia
- Being tested
- Parenteral Nutrition (PN) Premixed Olimel N9E
- Keywords
- Parenteral Nutrition, Hyperkalemia, Hypermagnesemia, Hyperphosphatemia, Hypercalcemia
- Medical subject headings
- Hyperphosphatemia, Hyperkalemia, Hypercalcemia, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral Nutrition (PN) Premixed Olimel N9ECombination product
Also called Olimel N9E
Parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort | Starting premixed Olimel N9E and follow for electrolyte irregularities. Receives: Combination Product: Parenteral Nutrition (PN) Premixed Olimel N9E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of shifting of Olimel N9E premixed formula to compounded PN secondary to the development of elevated electrolyte levels in surgical patients receiving PN.
Serum phosphate level of > 1.45 mmol/L, serum potassium level > 5.0 mmol/L, and serum magnesium level > 1.0 mmol/L.
Measured: Until cessation of parenteral nutritional support or after 30 days of PN support have elapsed.
Secondary outcomes (2)
Rate of high serum levels of phosphate, magnesium, calcium, and potassium.
serum phosphate level of > 1.45 mmol/L, serum potassium level > 5.0 mmol/L, and serum magnesium level > 1.0 mmol/L
Measured: Until cessation of parenteral nutritional support or after 30 days of PN support have elapsed
Risk factors associated with the development of hyperphosphatemia
Serum phosphate level of > 1.45 mmol/L
Measured: Until cessation of parenteral nutritional support or after 30 days of PN support have elapsed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start2 Feb 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakeam Abdulaziz Hakeam, King Faisal Specialist Hospital & Research Center
- Investigators
- Hakeam Hakeam, MS Pharm, Principal investigator, King Faisal Specialist Hospital and Research Centre (KFSH&RC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256369
- Sponsor's protocol ID
- 2191316
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On publication, according to the journal requirements.
Publications
Maisonneuve N, Raguso CA, Paoloni-Giacobino A, Muhlebach S, Corriol O, Saubion JL, Hecq JD, Bailly A, Berger M, Pichard C. Parenteral nutrition practices in hospital pharmacies in Switzerland, France, and Belgium. Nutrition. 2004 Jun;20(6):528-35. doi: 10.1016/j.nut.2004.03.020.
PubMed 15165615Hall JW. Safety, cost, and clinical considerations for the use of premixed parenteral nutrition. Nutr Clin Pract. 2015 Jun;30(3):325-30. doi: 10.1177/0884533615578459. Epub 2015 Apr 10.
PubMed 25862011DeLegge MH. Parenteral nutrition therapy over the next 5-10 years: where are we heading? JPEN J Parenter Enteral Nutr. 2012 Mar;36(2 Suppl):56S-61S. doi: 10.1177/0148607111435333. Epub 2012 Feb 2.
PubMed 22301323Pontes-Arruda A, Zaloga G, Wischmeyer P, Turpin R, Liu FX, Mercaldi C. Is there a difference in bloodstream infections in critically ill patients associated with ready-to-use versus compounded parenteral nutrition? Clin Nutr. 2012 Oct;31(5):728-34. doi: 10.1016/j.clnu.2012.03.004. Epub 2012 May 8.
PubMed 22572624Berlana D, Almendral MA, Abad MR, Fernandez A, Torralba A, Cervera-Peris M, Pineiro G, Romero-Jimenez R, Vazquez A, Ramirez E, Yebenes M, Munoz A. Cost, Time, and Error Assessment During Preparation of Parenteral Nutrition: Multichamber Bags Versus Hospital-Compounded Bags. JPEN J Parenter Enteral Nutr. 2019 May;43(4):557-565. doi: 10.1002/jpen.1436. Epub 2018 Aug 29.
PubMed 30156305Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
PubMed 28385477Hardy G, Puzovic M. Formulation, stability, and administration of parenteral nutrition with new lipid emulsions. Nutr Clin Pract. 2009 Oct-Nov;24(5):616-25. doi: 10.1177/0884533609342445.
PubMed 19841249Biesalski HK, Bischoff SC, Boehles HJ, Muehlhoefer A; Working group for developing the guidelines for parenteral nutrition of The German Association for Nutritional Medicine. Water, electrolytes, vitamins and trace elements - Guidelines on Parenteral Nutrition, Chapter 7. Ger Med Sci. 2009 Nov 18;7:Doc21. doi: 10.3205/000080.
PubMed 20049067Boullata JI, Gilbert K, Sacks G, Labossiere RJ, Crill C, Goday P, Kumpf VJ, Mattox TW, Plogsted S, Holcombe B; American Society for Parenteral and Enteral Nutrition. A.S.P.E.N. clinical guidelines: parenteral nutrition ordering, order review, compounding, labeling, and dispensing. JPEN J Parenter Enteral Nutr. 2014 Mar-Apr;38(3):334-77. doi: 10.1177/0148607114521833. Epub 2014 Feb 14.
PubMed 24531708Beattie C, Allard J, Raman M. Comparison Between Premixed and Compounded Parenteral Nutrition Solutions in Hospitalized Patients Requiring Parenteral Nutrition. Nutr Clin Pract. 2016 Apr;31(2):229-34. doi: 10.1177/0884533615621046. Epub 2016 Feb 17.
PubMed 26888855Fantoni D, Shih AC. Perioperative Fluid Therapy. Vet Clin North Am Small Anim Pract. 2017 Mar;47(2):423-434. doi: 10.1016/j.cvsm.2016.11.004.
PubMed 28164837Peppers MP, Geheb M, Desai T. Endocrine crises. Hypophosphatemia and hyperphosphatemia. Crit Care Clin. 1991 Jan;7(1):201-14.
PubMed 2007215Vernon WB, Atkins JM, Stewart RD. Hyperphosphatemia from lipid emulsion in a patient on total parenteral nutrition. JPEN J Parenter Enteral Nutr. 1988 Jan-Feb;12(1):84-7. doi: 10.1177/014860718801200184.
PubMed 3125363Nyirenda MJ, Tang JI, Padfield PL, Seckl JR. Hyperkalaemia. BMJ. 2009 Oct 23;339:b4114. doi: 10.1136/bmj.b4114. No abstract available.
PubMed 19854840Mendoza J, Legido J, Rubio S, Gisbert JP. Systematic review: the adverse effects of sodium phosphate enema. Aliment Pharmacol Ther. 2007 Jul 1;26(1):9-20. doi: 10.1111/j.1365-2036.2007.03354.x.
PubMed 17555417
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Termination of Commercial Premixed Parenteral Nutrition (PN) in Surgical Patients Secondary to High Serum Electrolyte Levels
- ClinicalTrials.gov ID
- NCT04256369
- Acronym / sponsor ID
- 2191316
- Conditions
- Hyperphosphatemia, Hyperkalemia, Hypermagnesemia, Hypercalcemia
- Keywords
- Parenteral Nutrition, Hyperkalemia, Hypermagnesemia, Hyperphosphatemia, Hypercalcemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Cohort | – | Combination Product: Parenteral Nutrition (PN) Premixed Olimel N9EStarting premixed Olimel N9E and follow for electrolyte irregularities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Parenteral Nutrition (PN) Premixed Olimel N9EAlso: Olimel N9EParenteral nutrition | Combination product | Primary Cohort |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Background: PubMed 15165615Maisonneuve N, Raguso CA, Paoloni-Giacobino A, Muhlebach S, Corriol O, Saubion JL, Hecq JD, Bailly A, Berger M, Pichard C. Parenteral nutrition practices in hospital pharmacies in Switzerland, France, and Belgium. Nutrition. 2004 Jun;20(6):528-35. doi: 10.1016/j.nut.2004.03.020.
- Background: PubMed 25862011Hall JW. Safety, cost, and clinical considerations for the use of premixed parenteral nutrition. Nutr Clin Pract. 2015 Jun;30(3):325-30. doi: 10.1177/0884533615578459. Epub 2015 Apr 10.
- Background: PubMed 22301323DeLegge MH. Parenteral nutrition therapy over the next 5-10 years: where are we heading? JPEN J Parenter Enteral Nutr. 2012 Mar;36(2 Suppl):56S-61S. doi: 10.1177/0148607111435333. Epub 2012 Feb 2.
- Background: PubMed 22572624Pontes-Arruda A, Zaloga G, Wischmeyer P, Turpin R, Liu FX, Mercaldi C. Is there a difference in bloodstream infections in critically ill patients associated with ready-to-use versus compounded parenteral nutrition? Clin Nutr. 2012 Oct;31(5):728-34. doi: 10.1016/j.clnu.2012.03.004. Epub 2012 May 8.
- Background: PubMed 30156305Berlana D, Almendral MA, Abad MR, Fernandez A, Torralba A, Cervera-Peris M, Pineiro G, Romero-Jimenez R, Vazquez A, Ramirez E, Yebenes M, Munoz A. Cost, Time, and Error Assessment During Preparation of Parenteral Nutrition: Multichamber Bags Versus Hospital-Compounded Bags. JPEN J Parenter Enteral Nutr. 2019 May;43(4):557-565. doi: 10.1002/jpen.1436. Epub 2018 Aug 29.
- Background: PubMed 28385477Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
- Background: PubMed 19841249Hardy G, Puzovic M. Formulation, stability, and administration of parenteral nutrition with new lipid emulsions. Nutr Clin Pract. 2009 Oct-Nov;24(5):616-25. doi: 10.1177/0884533609342445.
- Background: PubMed 20049067Biesalski HK, Bischoff SC, Boehles HJ, Muehlhoefer A; Working group for developing the guidelines for parenteral nutrition of The German Association for Nutritional Medicine. Water, electrolytes, vitamins and trace elements - Guidelines on Parenteral Nutrition, Chapter 7. Ger Med Sci. 2009 Nov 18;7:Doc21. doi: 10.3205/000080.
- Background: PubMed 24531708Boullata JI, Gilbert K, Sacks G, Labossiere RJ, Crill C, Goday P, Kumpf VJ, Mattox TW, Plogsted S, Holcombe B; American Society for Parenteral and Enteral Nutrition. A.S.P.E.N. clinical guidelines: parenteral nutrition ordering, order review, compounding, labeling, and dispensing. JPEN J Parenter Enteral Nutr. 2014 Mar-Apr;38(3):334-77. doi: 10.1177/0148607114521833. Epub 2014 Feb 14.
- Background: PubMed 26888855Beattie C, Allard J, Raman M. Comparison Between Premixed and Compounded Parenteral Nutrition Solutions in Hospitalized Patients Requiring Parenteral Nutrition. Nutr Clin Pract. 2016 Apr;31(2):229-34. doi: 10.1177/0884533615621046. Epub 2016 Feb 17.
- Background: PubMed 28164837Fantoni D, Shih AC. Perioperative Fluid Therapy. Vet Clin North Am Small Anim Pract. 2017 Mar;47(2):423-434. doi: 10.1016/j.cvsm.2016.11.004.
- Background: PubMed 2007215Peppers MP, Geheb M, Desai T. Endocrine crises. Hypophosphatemia and hyperphosphatemia. Crit Care Clin. 1991 Jan;7(1):201-14.
- Individual participant dataSharing planned: Yes. On publication, according to the journal requirements.
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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.
Hakeam Hakeam, MS Pharm principal investigator
King Faisal Specialist Hospital and Research Centre (KFSH&RC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphatemia and Hyperkalemia, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 NCT04256369, which also lists 19 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 3 Feb 2022.