Healthy Adult VolunteersPhase 4MIHMoSANCT02822898
Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults
A Phase 4 study testing NaCl 0.9% in Glucose 5% with 40mEq Potassium and Glucion 5% in people with Healthy Adult Volunteers, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The prescription of intravenous maintenance solutions - although widespread - lacks important data on the optimal sodium and potassium content, which has given rise to an important debate in the scientific literature. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- NaCl 0.9% in Glucose 5% with 40mEq Potassium and Glucion 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to Aug 2016
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults, 18-70 years of age
- BMI 17-45 kg/m².
- Creatinine clearance >60 ml/min (according to eGFR CKD-EPI formula).
Who cannot join
- Acute medical illness within 3 weeks of first study period
- Chronic medication: under diuretic therapy or other chronic medication that interfere with urine output or induce urine retention. All chronic medication should be declared before being enrolled in the study.
- Medical history:
- cardiac failure,
- malnourishment,
- diabetes mellitus,
Show all 9Show fewer
- urological disease preventing spontaneous or complete emptying of the bladder,
- any medical or non-medical issue preventing complaint-free fasting for 48 hours (e.g. active peptic ulcer, psychosis, substance abuse…)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults, a Single-Blind Randomized Crossover Trial
The prescription of intravenous maintenance solutions - although widespread - lacks important data on the optimal sodium and potassium content, which has given rise to an important debate in the scientific literature. Our study compares two different infusion fluids in 12 healthy adult volunteers without renal failure in a single-blind randomized crossover design over two 48 hour periods during which subjects are not allowed to eat or drink. Fluid 1 is a premixed solution containing 54 mmol/L of sodium and 26 mmol/L of potassium; fluid 2 is sodium chloride 0.9% in glucose 5% with 40 mmol/L of potassium. Both solutions are administered at 25 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both solutions is assessed by sequential analysis of urine and serum, clinical parameters and bioelectrical impedance analysis.
- Conditions
- Healthy Adult Volunteers
- Being tested
- NaCl 0.9% in Glucose 5% with 40mEq Potassium, Glucion 5%
- Keywords
- Maintenance, Intravenous solutions, Intravenous fluids, Tonicity, Potassium, Sodium, Fluid retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 0.9% in Glucose 5% with 40mEq PotassiumDrug
NaCl 0.9% in Glucose 5% with 40mEq Potassium, administered at 25 mL/kg IBW/h for 48h
Glucion 5%Drug
Glucion 5% (premixed solution containing 54 mmol/L sodium and 26 mmol/L potassium amongst others), administered at 25 mL/kg IBW/h for 48h
| Study group | Role | What they receive |
|---|---|---|
| Isotonic Maintenance Fluid | Active comparator | Isotonic Maintenance Fluid Receives: Drug: NaCl 0.9% in Glucose 5% with 40mEq Potassium |
| Hypotonic Maintenance Fluid | Active comparator | Hypotonic Maintenance Fluid Receives: Drug: Glucion 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Output
Urinary output over study period (as AUC).
Measured: 48h
Body weight
Body weight over study period (as AUC), used as a back up parameter for urinary output.
Measured: 48h
Secondary outcomes (4)
Amount of sodium retention / excretion (excreted sodium / administered sodium)
Sodium retention / excretion over study period (mean at 24 and 48h)
Measured: 48h
Number of episodes of hypokalemia (<3.5 mmol/L), hyponatremia (<135 mmol/L), hypernatremia (>145 mmol/L)
Measured: 48h
Change of sodium level from its baseline value.
Area under the electrolyte concentration curve (baseline level is reference line)
Measured: 48h
Change of sodium and potassium level from its baseline value.
Area under the electrolyte concentration curve (baseline level is reference line)
Measured: 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Niels Van Regenmortel, University Hospital, Antwerp
- Investigators
- Niels Van Regenmortel, M.D., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822898
- Sponsor's protocol ID
- 16/15/175
- Acronym
- MIHMoSA
- Status last verified
- Aug 2016
- First submitted
- 27 Jun 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lobo DN, Bostock KA, Neal KR, Perkins AC, Rowlands BJ, Allison SP. Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet. 2002 May 25;359(9320):1812-8. doi: 10.1016/S0140-6736(02)08711-1.
PubMed 12044376Moritz ML, Ayus JC. Maintenance Intravenous Fluids in Acutely Ill Patients. N Engl J Med. 2015 Oct;373(14):1350-60. doi: 10.1056/NEJMra1412877. No abstract available.
PubMed 26422725Van Regenmortel N, De Weerdt T, Van Craenenbroeck AH, Roelant E, Verbrugghe W, Dams K, Malbrain MLNG, Van den Wyngaert T, Jorens PG. Effect of isotonic versus hypotonic maintenance fluid therapy on urine output, fluid balance, and electrolyte homeostasis: a crossover study in fasting adult volunteers. Br J Anaesth. 2017 Jun 1;118(6):892-900. doi: 10.1093/bja/aex118.
PubMed 28520883
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults, a Single-Blind Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT02822898
- Acronym / sponsor ID
- MIHMoSA / 16/15/175
- Conditions
- Healthy Adult Volunteers
- Keywords
- Maintenance, Intravenous solutions, Intravenous fluids, Tonicity, Potassium, Sodium, Fluid retention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Jul 2016 (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.
The prescription of intravenous maintenance solutions - although widespread - lacks important data on the optimal sodium and potassium content, which has given rise to an important debate in the scientific literature. Our study compares two different infusion fluids in 12 healthy adult volunteers without renal failure in a single-blind randomized crossover design over two 48 hour periods during which subjects are not allowed to eat or drink. Fluid 1 is a premixed solution containing 54 mmol/L of sodium and 26 mmol/L of potassium; fluid 2 is sodium chloride 0.9% in glucose 5% with 40 mmol/L of potassium. Both solutions are administered at 25 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both solutions is assessed by sequential analysis of urine and serum, clinical parameters and bioelectrical impedance analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotonic Maintenance Fluid | Active comparator | Drug: NaCl 0.9% in Glucose 5% with 40mEq PotassiumIsotonic Maintenance Fluid |
| Hypotonic Maintenance Fluid | Active comparator | Drug: Glucion 5%Hypotonic Maintenance Fluid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults, 18-70 years of age
- BMI 17-45 kg/m².
- Creatinine clearance >60 ml/min (according to eGFR CKD-EPI formula).
Key exclusion criteria (9 listed)
- Acute medical illness within 3 weeks of first study period
- Chronic medication: under diuretic therapy or other chronic medication that interfere with urine output or induce urine retention. All chronic medication should be declared before being enrolled in the study.
- Medical history:
- any medical or non-medical issue preventing complaint-free fasting for 48 hours (e.g. active peptic ulcer, psychosis, substance abuse…)
- Pregnancy
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 |
|---|---|---|
| NaCl 0.9% in Glucose 5% with 40mEq PotassiumNaCl 0.9% in Glucose 5% with 40mEq Potassium, administered at 25 mL/kg IBW/h for 48h | Drug | Isotonic Maintenance Fluid |
| Glucion 5%Glucion 5% (premixed solution containing 54 mmol/L sodium and 26 mmol/L potassium amongst others), administered at 25 mL/kg IBW/h for 48h | Drug | Hypotonic Maintenance Fluid |
Primary outcome
Urine Output
Time frame: 48h
Urinary output over study period (as AUC).
Body weight
Time frame: 48h
Body weight over study period (as AUC), used as a back up parameter for urinary output.
4 secondary outcomes
Amount of sodium retention / excretion (excreted sodium / administered sodium)
Time frame: 48h
Number of episodes of hypokalemia (<3.5 mmol/L), hyponatremia (<135 mmol/L), hypernatremia (>145 mmol/L)
Time frame: 48h
Change of sodium level from its baseline value.
Time frame: 48h
Change of sodium and potassium level from its baseline value.
Time frame: 48h
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 9 Aug 2016.
- Background: PubMed 12044376Lobo DN, Bostock KA, Neal KR, Perkins AC, Rowlands BJ, Allison SP. Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet. 2002 May 25;359(9320):1812-8. doi: 10.1016/S0140-6736(02)08711-1.
- Background: PubMed 26422725Moritz ML, Ayus JC. Maintenance Intravenous Fluids in Acutely Ill Patients. N Engl J Med. 2015 Oct;373(14):1350-60. doi: 10.1056/NEJMra1412877. No abstract available.
- Derived from this study: PubMed 28520883Van Regenmortel N, De Weerdt T, Van Craenenbroeck AH, Roelant E, Verbrugghe W, Dams K, Malbrain MLNG, Van den Wyngaert T, Jorens PG. Effect of isotonic versus hypotonic maintenance fluid therapy on urine output, fluid balance, and electrolyte homeostasis: a crossover study in fasting adult volunteers. Br J Anaesth. 2017 Jun 1;118(6):892-900. doi: 10.1093/bja/aex118.
- NICE guideline on Intravenous Fluid Therapy in Adults in HospitalLink provided by the sponsor.
- GIFTASUP guidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Niels Van Regenmortel, M.D. principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NaCl 0.9% in Glucose 5% with 40mEq Potassium and Glucion 5% in people with Healthy Adult Volunteers, run by University Hospital, Antwerp at 1 site in Belgium.
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 3 inclusion and 9 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 9 Aug 2016. 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 Belgium. 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?
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?
Urine Output (time frame: 48h). The study lists 2 primary outcomes in all. 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 NCT02822898, which also lists 3 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 9 Aug 2016.