Pediatric SurgeryNCT05061836
Effect of Using Dextrose-containing Intraoperative Fluid in Children
A study testing Ringer acetate, 1.25%Dextrose equivalence and 2.5%Dextrose equivalence in people with Pediatric Surgery, run by Mahidol University at 1 site in Thailand.
Trial summary
The glucose-containing fluid was preferred for maintenance fluid in pediatric surgery to prevent hypoglycemic events. This practice can lead to intraoperative hyperglycemia which can induce osmotic diuresis and consequently dehydration and electrolyte disturbances. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Pediatric Surgery
- What is being tested?
- Ringer acetate, 1.25%Dextrose equivalence and 2.5%Dextrose equivalence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2021to Dec 2022
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged of 1 to 5 years
- ASA physical status 1 and 2
- Schedule for elective non-abdominal surgery between 1-3 hours under general anesthesia without anticipation of major blood loss at Siriraj Hospital.
Who cannot join
- Patients with severe neurologic, cardiac, endocrine, or metabolic disease
- Patients receiving intravenous fluid preoperatively
- Patients with history or have known risk of hypoglycemia
- Patient with severe liver dysfunction
- Withdrawal or termination criteria
- Patients requiring intraoperative blood product transfusion or inotropes infusion
- Patients who have preoperative hypoglycemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Using Dextrose-containing Intraoperative Fluid in Children: a Randomized Controlled Trial
The glucose-containing fluid was preferred for maintenance fluid in pediatric surgery to prevent hypoglycemic events. This practice can lead to intraoperative hyperglycemia which can induce osmotic diuresis and consequently dehydration and electrolyte disturbances.
As an anesthesiologist, the use of glucose-containing fluid should be reconsidered to avoid these undesirable effects in pediatric surgery.
Our study aims to identify an appropriate use of 5% dextrose containing solution during intraoperative period in children (2 age groups: 1-2 vs 3-5 years old) that can prevent glucose and lipid mobilization without causing hypo/hyperglycemia and provide adequate fluid maintenance in the context of hospitals in Thailand
Read the detailed description
- In this randomized controlled trial, the investigator will find the difference in pre and postoperative value of base excess among the different fluid groups which is an acid-base parameter indicating volume status and mobilization of lipid stores in each age group (2 age group: 1-2 vs 3-5 years old). Each age group will be divided to:
- Group D0: patients will receive Acetate Ringer's solution (Acetar) infused at maintenance rate
- Group D1: 5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate [resulted in 1.25%dextrose equivalence]
- Group D2: 5%DNSS infused ½ of maintenance rate [resulted in 2.5%dextrose equivalence]
- Group D5: 5%DNSS infused with maintenance rate
- Patient will be fasting as standard preoperative fasting protocol, and received 5 ml/kg of water at 3 hours prior to surgery
- After standard anesthesia induction and intravenous line (IV) placement, the blood samples will be collected and the POCT glucose will be re-evaluated every 1 hour through the operation to avoid intraoperative hypo/hyperglycemia.
- The first blood sample will be collected after IV line placement and the second blood sample will be collected at the end of surgery. Both blood samples will be sent to the lab to measure blood glucose, serum electrolytes (sodium, potassium, and chloride), acid-base parameters (pH, base excess, standardized bicarbonate, anion gap), endocrine parameters (serum insulin, glucagon, cortisol), and metabolic parameters (free fatty acid, serum ketone, serum lactate).
- Conditions
- Pediatric Surgery
- Being tested
- Ringer acetate, 1.25%Dextrose equivalence, 2.5%Dextrose equivalence, Dextrose 5
- Keywords
- Glucose containing solution, Dextrose containing solution, Dextrose-saline solution, Pediatric fluid, Pediatric hyperglycemia, Pediatric hypoglycemia, Intraoperative glucose, Intraoperative fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer acetateDrug
Patient will receive Acetate Ringer's solution (Acetar) infused at maintenance rate
1.25%Dextrose equivalenceDrug
5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate
2.5%Dextrose equivalenceDrug
5%dextrose in normal saline (5%DNSS) infused ½ of maintenance rate
Dextrose 5Drug
5%dextrose in normal saline (5%DNSS) infused with maintenance rate
| Study group | Role | What they receive |
|---|---|---|
| Dextrose0 | Experimental | Acetate Ringer's solution Receives: Drug: Ringer acetate |
| Dextrose1 | Experimental | 1.25%dextrose equivalence Receives: Drug: 1.25%Dextrose equivalence |
| Dextrose2 | Experimental | 2.5%dextrose equivalence Receives: Drug: 2.5%Dextrose equivalence |
| Dextrose5 | Active comparator | 5%dextrose Receives: Drug: Dextrose 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in pre and postoperative value of base excess
To find the difference in pre and postoperative value of base excess among the different fluid groups which is an acid-base parameter indicating volume status and mobilization of lipid stores in each age group.
Measured: 1 day
Secondary outcomes (4)
The difference in postoperative value of other acid-base, metabolic, and endocrine parameters
To find the difference in postoperative value of other acid-base, metabolic, and endocrine parameters that indicate mobilization of glucose and lipid stores of each group with different maintenance rate of fluid in each age group and between age group.
Measured: 1 day
Incidence of postoperative base excess value that equal or more negative than -5 of each group
To find the incidence of postoperative base excess value that equal or more negative than -5 of each group with different maintenance rate of fluid in each age group and between age group.
Measured: 1 day
The difference in perioperative blood glucose level among the groups
To find the difference in perioperative blood glucose level among the groups measured during surgery of each group with different maintenance rate of fluid in each age group and between age group.
Measured: 1 day
Incidence of hypotension of each group
To find the incidence of hypotension of each group with different maintenance rate of fluid in each age group and between age group
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pediatric SurgeryStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, patcharee sriswasdi, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061836
- Sponsor's protocol ID
- 12345
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nilsson K, Larsson LE, Andreasson S, Ekstrom-Jodal B. Blood-glucose concentrations during anaesthesia in children. Effects of starvation and perioperative fluid therapy. Br J Anaesth. 1984 Apr;56(4):375-9. doi: 10.1093/bja/56.4.375.
PubMed 6712852Barua K, Rajan S, Paul J, Tosh P, Padmalayan A, Kumar L. Effect of Using Ringer's Lactate, with and without Addition of Dextrose, on Intra-Operative Blood Sugar Levels in Infants Undergoing Facial Cleft Surgeries. Anesth Essays Res. 2018 Apr-Jun;12(2):297-301. doi: 10.4103/aer.AER_53_18.
PubMed 29962586Suraseranivongse S, Attachoo A, Leelanukrom R, Chareonsawan U, Horatanaruang D. National survey of pediatric anesthesia practice in Thailand. J Med Assoc Thai. 2011 Apr;94(4):450-6.
PubMed 21591530Sieber FE, Smith DS, Traystman RJ, Wollman H. Glucose: a reevaluation of its intraoperative use. Anesthesiology. 1987 Jul;67(1):72-81. No abstract available.
PubMed 3111308Lanier WL, Stangland KJ, Scheithauer BW, Milde JH, Michenfelder JD. The effects of dextrose infusion and head position on neurologic outcome after complete cerebral ischemia in primates: examination of a model. Anesthesiology. 1987 Jan;66(1):39-48. doi: 10.1097/00000542-198701000-00008.
PubMed 3800033Nishina K, Mikawa K, Maekawa N, Asano M, Obara H. Effects of exogenous intravenous glucose on plasma glucose and lipid homeostasis in anesthetized infants. Anesthesiology. 1995 Aug;83(2):258-63. doi: 10.1097/00000542-199508000-00004.
PubMed 7631946Sumpelmann R, Becke K, Crean P, Johr M, Lonnqvist PA, Strauss JM, Veyckemans F; German Scientific Working Group for Paediatric Anaesthesia. European consensus statement for intraoperative fluid therapy in children. Eur J Anaesthesiol. 2011 Sep;28(9):637-9. doi: 10.1097/EJA.0b013e3283446bb8.
PubMed 21654319Datta PK, Pawar DK, Baidya DK, Maitra S, Aravindan A, Srinivas M, Lakshmy R, Gupta N, Bajpai M, Bhatnagar V, Agarwala S. Dextrose-containing intraoperative fluid in neonates: a randomized controlled trial. Paediatr Anaesth. 2016 Jun;26(6):599-607. doi: 10.1111/pan.12886. Epub 2016 Apr 16.
PubMed 27083135HOLLIDAY MA, SEGAR WE. The maintenance need for water in parenteral fluid therapy. Pediatrics. 1957 May;19(5):823-32. No abstract available.
PubMed 13431307Davis JW, Shackford SR, Mackersie RC, Hoyt DB. Base deficit as a guide to volume resuscitation. J Trauma. 1988 Oct;28(10):1464-7. doi: 10.1097/00005373-198810000-00010.
PubMed 3172306Beath SV. Hepatic function and physiology in the newborn. Semin Neonatol. 2003 Oct;8(5):337-46. doi: 10.1016/S1084-2756(03)00066-6.
PubMed 15001122
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Dextrose-containing Intraoperative Fluid in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05061836
- Acronym / sponsor ID
- 12345
- Conditions
- Pediatric Surgery
- Keywords
- Glucose containing solution, Dextrose containing solution, Dextrose-saline solution, Pediatric fluid, Pediatric hyperglycemia, Pediatric hypoglycemia, Intraoperative glucose, Intraoperative fluid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Sep 2021 (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 glucose-containing fluid was preferred for maintenance fluid in pediatric surgery to prevent hypoglycemic events. This practice can lead to intraoperative hyperglycemia which can induce osmotic diuresis and consequently dehydration and electrolyte disturbances.
As an anesthesiologist, the use of glucose-containing fluid should be reconsidered to avoid these undesirable effects in pediatric surgery.
Our study aims to identify an appropriate use of 5% dextrose containing solution during intraoperative period in children (2 age groups: 1-2 vs 3-5 years old) that can prevent glucose and lipid mobilization without causing hypo/hyperglycemia and provide adequate fluid maintenance in the context of hospitals in Thailand
Detailed description
- In this randomized controlled trial, the investigator will find the difference in pre and postoperative value of base excess among the different fluid groups which is an acid-base parameter indicating volume status and mobilization of lipid stores in each age group (2 age group: 1-2 vs 3-5 years old). Each age group will be divided to:
- Group D0: patients will receive Acetate Ringer's solution (Acetar) infused at maintenance rate
- Group D1: 5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate [resulted in 1.25%dextrose equivalence]
- Group D2: 5%DNSS infused ½ of maintenance rate [resulted in 2.5%dextrose equivalence]
- Group D5: 5%DNSS infused with maintenance rate
- Patient will be fasting as standard preoperative fasting protocol, and received 5 ml/kg of water at 3 hours prior to surgery
- After standard anesthesia induction and intravenous line (IV) placement, the blood samples will be collected and the POCT glucose will be re-evaluated every 1 hour through the operation to avoid intraoperative hypo/hyperglycemia.
- The first blood sample will be collected after IV line placement and the second blood sample will be collected at the end of surgery. Both blood samples will be sent to the lab to measure blood glucose, serum electrolytes (sodium, potassium, and chloride), acid-base parameters (pH, base excess, standardized bicarbonate, anion gap), endocrine parameters (serum insulin, glucagon, cortisol), and metabolic parameters (free fatty acid, serum ketone, serum lactate).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dextrose0 | Experimental | Drug: Ringer acetateAcetate Ringer's solution |
| Dextrose1 | Experimental | Drug: 1.25%Dextrose equivalence1.25%dextrose equivalence |
| Dextrose2 | Experimental | Drug: 2.5%Dextrose equivalence2.5%dextrose equivalence |
| Dextrose5 | Active comparator | Drug: Dextrose 55%dextrose |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged of 1 to 5 years
- ASA physical status 1 and 2
- Schedule for elective non-abdominal surgery between 1-3 hours under general anesthesia without anticipation of major blood loss at Siriraj Hospital.
Key exclusion criteria (7 listed)
- Patients with severe neurologic, cardiac, endocrine, or metabolic disease
- Patients receiving intravenous fluid preoperatively
- Patients with history or have known risk of hypoglycemia
- Patient with severe liver dysfunction
- Withdrawal or termination criteria
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 |
|---|---|---|
| Ringer acetatePatient will receive Acetate Ringer's solution (Acetar) infused at maintenance rate | Drug | Dextrose0 |
| 1.25%Dextrose equivalence5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate | Drug | Dextrose1 |
| 2.5%Dextrose equivalence5%dextrose in normal saline (5%DNSS) infused ½ of maintenance rate | Drug | Dextrose2 |
| Dextrose 55%dextrose in normal saline (5%DNSS) infused with maintenance rate | Drug | Dextrose5 |
Primary outcome
The difference in pre and postoperative value of base excess
Time frame: 1 day
To find the difference in pre and postoperative value of base excess among the different fluid groups which is an acid-base parameter indicating volume status and mobilization of lipid stores in each age group.
4 secondary outcomes
The difference in postoperative value of other acid-base, metabolic, and endocrine parameters
Time frame: 1 day
Incidence of postoperative base excess value that equal or more negative than -5 of each group
Time frame: 1 day
The difference in perioperative blood glucose level among the groups
Time frame: 1 day
Incidence of hypotension of each group
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Background: PubMed 6712852Nilsson K, Larsson LE, Andreasson S, Ekstrom-Jodal B. Blood-glucose concentrations during anaesthesia in children. Effects of starvation and perioperative fluid therapy. Br J Anaesth. 1984 Apr;56(4):375-9. doi: 10.1093/bja/56.4.375.
- Background: PubMed 29962586Barua K, Rajan S, Paul J, Tosh P, Padmalayan A, Kumar L. Effect of Using Ringer's Lactate, with and without Addition of Dextrose, on Intra-Operative Blood Sugar Levels in Infants Undergoing Facial Cleft Surgeries. Anesth Essays Res. 2018 Apr-Jun;12(2):297-301. doi: 10.4103/aer.AER_53_18.
- Background: PubMed 21591530Suraseranivongse S, Attachoo A, Leelanukrom R, Chareonsawan U, Horatanaruang D. National survey of pediatric anesthesia practice in Thailand. J Med Assoc Thai. 2011 Apr;94(4):450-6.
- Background: PubMed 3111308Sieber FE, Smith DS, Traystman RJ, Wollman H. Glucose: a reevaluation of its intraoperative use. Anesthesiology. 1987 Jul;67(1):72-81. No abstract available.
- Background: PubMed 3800033Lanier WL, Stangland KJ, Scheithauer BW, Milde JH, Michenfelder JD. The effects of dextrose infusion and head position on neurologic outcome after complete cerebral ischemia in primates: examination of a model. Anesthesiology. 1987 Jan;66(1):39-48. doi: 10.1097/00000542-198701000-00008.
- Background: PubMed 7631946Nishina K, Mikawa K, Maekawa N, Asano M, Obara H. Effects of exogenous intravenous glucose on plasma glucose and lipid homeostasis in anesthetized infants. Anesthesiology. 1995 Aug;83(2):258-63. doi: 10.1097/00000542-199508000-00004.
- Background: PubMed 21654319Sumpelmann R, Becke K, Crean P, Johr M, Lonnqvist PA, Strauss JM, Veyckemans F; German Scientific Working Group for Paediatric Anaesthesia. European consensus statement for intraoperative fluid therapy in children. Eur J Anaesthesiol. 2011 Sep;28(9):637-9. doi: 10.1097/EJA.0b013e3283446bb8.
- Background: PubMed 27083135Datta PK, Pawar DK, Baidya DK, Maitra S, Aravindan A, Srinivas M, Lakshmy R, Gupta N, Bajpai M, Bhatnagar V, Agarwala S. Dextrose-containing intraoperative fluid in neonates: a randomized controlled trial. Paediatr Anaesth. 2016 Jun;26(6):599-607. doi: 10.1111/pan.12886. Epub 2016 Apr 16.
- Background: PubMed 13431307HOLLIDAY MA, SEGAR WE. The maintenance need for water in parenteral fluid therapy. Pediatrics. 1957 May;19(5):823-32. No abstract available.
- Background: PubMed 3172306Davis JW, Shackford SR, Mackersie RC, Hoyt DB. Base deficit as a guide to volume resuscitation. J Trauma. 1988 Oct;28(10):1464-7. doi: 10.1097/00005373-198810000-00010.
- Background: PubMed 15001122Beath SV. Hepatic function and physiology in the newborn. Semin Neonatol. 2003 Oct;8(5):337-46. doi: 10.1016/S1084-2756(03)00066-6.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer acetate, 1.25%Dextrose equivalence and 2.5%Dextrose equivalence in people with Pediatric Surgery, run by Mahidol University at 1 site in Thailand.
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 7 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 30 Sep 2021. 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 Thailand. 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 Patcharee Sriswasdi, MD (+66815500123, pat.si.research@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in pre and postoperative value of base excess (time frame: 1 day). 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 NCT05061836, which also lists 11 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 30 Sep 2021.