Fluid and Electrolyte ImbalanceNCT03599973
Correlation Between Duration of Fasting and Response to Fluid Replenishment, Evaluated With Repeated Measures of VTI.
A study testing Plasmalyte A Viaflo in people with Fluid and Electrolyte Imbalance and Fluid Therapy, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The investigators will study the correlation between the lenght of the fasting before surgery and the need to replenish with intra-venous fluids in children, evaluated with 3 measures of the aortic Integral Time Velocity with transthoracic echocardiography. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid and Electrolyte Imbalance, Fluid Therapy
- What is being tested?
- Plasmalyte A Viaflo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Aug 2018to 1 Jul 2019
- Phase
- Interventional
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 3 and 6 years with a normal ponderal evolution.
- Children with good general status (ASA 1)
- Children whose parents have given the informed authorization to do the study.
- Children seen in the consultation of anesthesiology.
- Children programed to have ambulatory surgery (Amygdalectomy, dental care, dental extraction).
Who cannot join
- Children with more than 6 years of age.
- Children whose parents didn't agree with the study.
- Children enrolled in another study on the 3 months before.
- Children with hearth or lung conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corrélation Entre la Longueur de jeûne et la réponse au Remplissage Vasculaire évaluée Par Des Mesures répétées de l'ITV.
The investigators will study the correlation between the lenght of the fasting before surgery and the need to replenish with intra-venous fluids in children, evaluated with 3 measures of the aortic Integral Time Velocity with transthoracic echocardiography.
- Conditions
- Fluid and Electrolyte Imbalance, Fluid Therapy
- Being tested
- Plasmalyte A Viaflo
- Keywords
- Rehydration Solutions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmalyte A ViafloOther
Fluid therapy to be given according to the principle of 4-2-1 (4 ml of crystalloid fluid for each of the first 10 kg of weight (0-10 kg), 2 ml of crystalloid fluid for each of the second 10 kg of weight (11-20 kg) and 1 ml of crystalloid fluid for each kg of weight over 20.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Other | One-arm study, where all patients are given the same standard fluidotherapy and anesthetic conditions to compare measures of Aortic VTI before and after the IV fluid. Receives: Other: Plasmalyte A Viaflo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic VTI change
Transthoracic echocardiography measures of the Time-Speed Interval in the aortic valve before fluid therapy (baseline) and after fluid therapy (20 ml/kg in 15 minutes).
Measured: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Secondary outcomes (3)
Blood pressure change
Analysis of the variation of Mean Arterial Blood pressure with fluid therapy
Measured: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Legs-up maneuver
Analysis of the variation of Mean Arterial Blood pressure with the legs up maneuver
Measured: From baseline analysis (t=5 min after anesthesia induction), to the end of legs-up maneuver (t = +/- 10 min).
Post-operative nausea and vomiting
Comparisson of the incidence of post-operative nausea and vomiting in the fluid respondeurs group vs non respondeurs.
Measured: From arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start15 Aug 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fluid and Electrolyte ImbalanceStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599973
- Sponsor's protocol ID
- ErasmeVTI2018
- Status last verified
- Jun 2018
- First submitted
- 13 Apr 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pees C, Glagau E, Hauser J, Michel-Behnke I. Reference values of aortic flow velocity integral in 1193 healthy infants, children, and adolescents to quickly estimate cardiac stroke volume. Pediatr Cardiol. 2013 Jun;34(5):1194-200. doi: 10.1007/s00246-012-0628-6. Epub 2013 Jan 24.
PubMed 23344893Wang J, Xu E, Xiao Y. Isotonic versus hypotonic maintenance IV fluids in hospitalized children: a meta-analysis. Pediatrics. 2014 Jan;133(1):105-13. doi: 10.1542/peds.2013-2041. Epub 2013 Dec 30.
PubMed 24379232Miller A, Mandeville J. Predicting and measuring fluid responsiveness with echocardiography. Echo Res Pract. 2016 Jun;3(2):G1-G12. doi: 10.1530/ERP-16-0008. Epub 2016 May 24.
PubMed 27249550Mercado P, Maizel J, Beyls C, Titeca-Beauport D, Joris M, Kontar L, Riviere A, Bonef O, Soupison T, Tribouilloy C, de Cagny B, Slama M. Transthoracic echocardiography: an accurate and precise method for estimating cardiac output in the critically ill patient. Crit Care. 2017 Jun 9;21(1):136. doi: 10.1186/s13054-017-1737-7.
PubMed 28595621Singh Y. Echocardiographic Evaluation of Hemodynamics in Neonates and Children. Front Pediatr. 2017 Sep 15;5:201. doi: 10.3389/fped.2017.00201. eCollection 2017.
PubMed 28966921Lopez L, Colan SD, Frommelt PC, Ensing GJ, Kendall K, Younoszai AK, Lai WW, Geva T. Recommendations for quantification methods during the performance of a pediatric echocardiogram: a report from the Pediatric Measurements Writing Group of the American Society of Echocardiography Pediatric and Congenital Heart Disease Council. J Am Soc Echocardiogr. 2010 May;23(5):465-95; quiz 576-7. doi: 10.1016/j.echo.2010.03.019. No abstract available.
PubMed 20451803Gaspar HA, Morhy SS. The Role of Focused Echocardiography in Pediatric Intensive Care: A Critical Appraisal. Biomed Res Int. 2015;2015:596451. doi: 10.1155/2015/596451. Epub 2015 Oct 28.
PubMed 26605333Lai WW, Geva T, Shirali GS, Frommelt PC, Humes RA, Brook MM, Pignatelli RH, Rychik J; Task Force of the Pediatric Council of the American Society of Echocardiography; Pediatric Council of the American Society of Echocardiography. Guidelines and standards for performance of a pediatric echocardiogram: a report from the Task Force of the Pediatric Council of the American Society of Echocardiography. J Am Soc Echocardiogr. 2006 Dec;19(12):1413-30. doi: 10.1016/j.echo.2006.09.001. No abstract available.
PubMed 17138024
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corrélation Entre la Longueur de jeûne et la réponse au Remplissage Vasculaire évaluée Par Des Mesures répétées de l'ITV.
- ClinicalTrials.gov ID
- NCT03599973
- Acronym / sponsor ID
- ErasmeVTI2018
- Conditions
- Fluid and Electrolyte Imbalance, Fluid Therapy
- Keywords
- Rehydration Solutions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 26 Jul 2018 (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.
The investigators will study the correlation between the lenght of the fasting before surgery and the need to replenish with intra-venous fluids in children, evaluated with 3 measures of the aortic Integral Time Velocity with transthoracic echocardiography.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Other | Other: Plasmalyte A ViafloOne-arm study, where all patients are given the same standard fluidotherapy and anesthetic conditions to compare measures of Aortic VTI before and after the IV fluid. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 3 and 6 years with a normal ponderal evolution.
- Children with good general status (ASA 1)
- Children whose parents have given the informed authorization to do the study.
- Children seen in the consultation of anesthesiology.
- Children programed to have ambulatory surgery (Amygdalectomy, dental care, dental extraction).
Key exclusion criteria (4 listed)
- Children with more than 6 years of age.
- Children whose parents didn't agree with the study.
- Children enrolled in another study on the 3 months before.
- Children with hearth or lung conditions.
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 |
|---|---|---|
| Plasmalyte A ViafloFluid therapy to be given according to the principle of 4-2-1 (4 ml of crystalloid fluid for each of the first 10 kg of weight (0-10 kg), 2 ml of crystalloid fluid for each of the second 10 kg of weight (11-20 kg) and 1 ml of crystalloid fluid for each kg of weight over 20. | Other | Patient |
Primary outcome
Aortic VTI change
Time frame: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Transthoracic echocardiography measures of the Time-Speed Interval in the aortic valve before fluid therapy (baseline) and after fluid therapy (20 ml/kg in 15 minutes).
3 secondary outcomes
Blood pressure change
Time frame: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Legs-up maneuver
Time frame: From baseline analysis (t=5 min after anesthesia induction), to the end of legs-up maneuver (t = +/- 10 min).
Post-operative nausea and vomiting
Time frame: From arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 23344893Pees C, Glagau E, Hauser J, Michel-Behnke I. Reference values of aortic flow velocity integral in 1193 healthy infants, children, and adolescents to quickly estimate cardiac stroke volume. Pediatr Cardiol. 2013 Jun;34(5):1194-200. doi: 10.1007/s00246-012-0628-6. Epub 2013 Jan 24.
- Background: PubMed 24379232Wang J, Xu E, Xiao Y. Isotonic versus hypotonic maintenance IV fluids in hospitalized children: a meta-analysis. Pediatrics. 2014 Jan;133(1):105-13. doi: 10.1542/peds.2013-2041. Epub 2013 Dec 30.
- Background: PubMed 27249550Miller A, Mandeville J. Predicting and measuring fluid responsiveness with echocardiography. Echo Res Pract. 2016 Jun;3(2):G1-G12. doi: 10.1530/ERP-16-0008. Epub 2016 May 24.
- Background: PubMed 28595621Mercado P, Maizel J, Beyls C, Titeca-Beauport D, Joris M, Kontar L, Riviere A, Bonef O, Soupison T, Tribouilloy C, de Cagny B, Slama M. Transthoracic echocardiography: an accurate and precise method for estimating cardiac output in the critically ill patient. Crit Care. 2017 Jun 9;21(1):136. doi: 10.1186/s13054-017-1737-7.
- Background: PubMed 28966921Singh Y. Echocardiographic Evaluation of Hemodynamics in Neonates and Children. Front Pediatr. 2017 Sep 15;5:201. doi: 10.3389/fped.2017.00201. eCollection 2017.
- Background: PubMed 20451803Lopez L, Colan SD, Frommelt PC, Ensing GJ, Kendall K, Younoszai AK, Lai WW, Geva T. Recommendations for quantification methods during the performance of a pediatric echocardiogram: a report from the Pediatric Measurements Writing Group of the American Society of Echocardiography Pediatric and Congenital Heart Disease Council. J Am Soc Echocardiogr. 2010 May;23(5):465-95; quiz 576-7. doi: 10.1016/j.echo.2010.03.019. No abstract available.
- Background: PubMed 26605333Gaspar HA, Morhy SS. The Role of Focused Echocardiography in Pediatric Intensive Care: A Critical Appraisal. Biomed Res Int. 2015;2015:596451. doi: 10.1155/2015/596451. Epub 2015 Oct 28.
- Background: PubMed 17138024Lai WW, Geva T, Shirali GS, Frommelt PC, Humes RA, Brook MM, Pignatelli RH, Rychik J; Task Force of the Pediatric Council of the American Society of Echocardiography; Pediatric Council of the American Society of Echocardiography. Guidelines and standards for performance of a pediatric echocardiogram: a report from the Task Force of the Pediatric Council of the American Society of Echocardiography. J Am Soc Echocardiogr. 2006 Dec;19(12):1413-30. doi: 10.1016/j.echo.2006.09.001. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Fluid and Electrolyte Imbalance
Active, not recruiting
BIA-Guided vs. Conventional Fluid Resuscitation in ICU Patients
Fluid and Electrolyte Imbalance, Anesthesia
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation
Not yet recruiting
Can Changes in Dialysate Sodium Concentration Improve Blood Pressure and Endothelial Function in Chronic HD Patients?
Dialysis Dependent Chronic Kidney Disease, Dialysis Patients
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmalyte A Viaflo in people with Fluid and Electrolyte Imbalance and Fluid Therapy, run by Erasme University Hospital 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 5 inclusion and 4 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 26 Jul 2018. 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.
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 Ionut Tabolcea, MD (0032488720046, ionutztb@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic VTI change (time frame: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).). 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 NCT03599973, which also lists 8 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 26 Jul 2018.