Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000833167
Ethics application status
Approved
Date submitted
12/03/2019
Date registered
11/06/2019
Date last updated
14/01/2024
Date data sharing statement initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of intraoperative maintenance fluid containing glucose 10 mg/ml to infants (1-12 moths old).
Scientific title
A safety and physiology-study of a near isotonic maintenance fluid containing 1 % glucose to infants (1-12 months old)
Secondary ID [1] 297660 0
Nil
Universal Trial Number (UTN)
U1111-1229-7186
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraoperative prevalence of hypoglycemia


 311937 0
Intraoperative prevalence of hyperglycemia 311938 0
Intraoperative endogenous glucose production 312075 0
Intraoperative prevalence of hyponatremia 312076 0
Intraoperative endogenous energy production 312077 0
Intraoperative change in ketone concentration 312078 0
Condition category
Condition code
Anaesthesiology 310519 310519 0 0
Other anaesthesiology
Metabolic and Endocrine 310520 310520 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main objective of this observational study is to investigate if normoglycemia is maintained when a near isotonic maintenance fluid containing 1 % glucose is given intraoperatively to infants (1-12 moths of age). (n=375).
The administered 1% glucose near-isotonic maintenance fluid will be given as a continous infusion during the whole intraoperative period ,5 ml/kg/hour for minor surgery, 7 ml/kg/hour for moderate surgery and 10 ml/kg/hour for major surgery. This is the only intravenous maintenance fluid that will be given intraoperatively. Using near-isotonic 1% glucose solution for this age group is not yet clinical practice at our department , mostly due to fear of hypoglycemia. However, this solution is widely recommended, including European Society of Pediatric anesthesia. This study focus upon a specific age cohort with possible risk of hypoglycemia. and include a relatively large number of patients. We believe that the recommendations can be substantiated with the results from this study.
Plasma glucose concentration (blood-gas analysis) will be determined at induction of anesthesia and then every 30 minutes during surgery.
In the blood-gas analysis also sodium will be analysed.
The concentration of ketone bodies will be measured at induction and at the end of surgery.
The time of fasting will be determined and related to glucose- and ketoneconcentration.
In a subgroup of subjects undergoing major surgery with expected duration > 60 minutes, endogenous glucose production and energy production will be determined using stabile isotope (6.6-D2-glucose) and indirect calorimetry respectively.
Intervention code [1] 313895 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319379 0
Plasma glucose concentration
Timepoint [1] 319379 0
End of surgery/anesthesia.
Primary outcome [2] 319381 0
Plasma sodium concentration
Timepoint [2] 319381 0
End of surgery/anesthesia
Secondary outcome [1] 367960 0
Endogenous glucose production rate. This will be investigated in a subgroup of subjects undergoing major surgery with expected duration > 60 minutes. Endogenous glucose production will be determined using stabile isotope (6.6-D2-glucose).
Timepoint [1] 367960 0
The stable isotop 6.6-D2-glucose will be given as a prime - constant infusion during anesthesia/surgery. In parallell, glucose from the near-isotonic glucose infusion is given at a known rate. At later analysis the quotient 6.6-D2-glucose/glucose will be determined. Thereby endogenous glucose production can be determined.
Secondary outcome [2] 367962 0
Energy production will be determined using indirect calorimetry.
Timepoint [2] 367962 0
Investigation of energy production will be performed 30 to 60 minutes after anesthesia induction.
Secondary outcome [3] 367963 0
Change in ketone concentration in blood from anesthesia induction until end of surgery using a established laboratory method.
Timepoint [3] 367963 0
Ketone concentration will be determined at anesthesia induction and at the end of surgery.
Secondary outcome [4] 367964 0
Change in lactate concentration during surgery using blood gas analysis.
Timepoint [4] 367964 0
Change in plasma lactate concentration will be determined at anesthesia induction and at the end of surgery.
Secondary outcome [5] 367965 0
Duration of fasting. This time will be obtained just prio to anesthesia induction by asking the parents.
Timepoint [5] 367965 0
Preoperatively.The fasting time will be obtained just prio to anesthesia induction by asking the parents.

Eligibility
Key inclusion criteria
Infants undergoing surgery at Karolinska University Hospital, Stockholm Sweden.
Minimum age
1 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Metabolic and/or endocrinology disease, liver disease affecting liver function, malnutrition, small for gestational age at birth (>2 standard deviations), ongoing medication with beta-blocker, preoperatively parenteral nutrition, preoperative glucose infusion of > 6 hours, plasma glucose concentration < 3.0 mmol/L at induction of anesthesia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Power calculations are based on possible incidence of hypoglycemia occurring intraoperatively to infants (1-12 months) undergoing surgery given near-isotonic maintenance fluid containing 1 % glucose at a infusion rate of 5-10 ml/kg/hour. If patients (n=375) are investigated, this will result in a 95 % confidence intervall of (0-0.012) assuming a proportion of 0.999. Assuming that the proportion of patients that will develop hypoglycemia (< 3.0 mmol/L) is 1/1000 and none of the patients in the study (n=375) develop hypoglycemia, It can be assumed that the risk of developing hypoglycemia is maximally 1 %. This is hypothetical since the true incidence of hypoglycemia under these conditions are and will remain unknown. However, given that no patient in this study develop hypoglycemia, the resulting confidence interval will be 0.01, that is from 0.99 to 1.0. The risk of the incidence being outside this interval is 5 %.
Data will be tested for normality using D’Agostino & Pearson omnibus normality test. Parametric or non-parametric statistics will be used as appropriate to investigate differences in glucose-, ketone- and sodium concentration from induction of anesthesia to end of surgery.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/09/2019
Actual
16/09/2019
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
375
Accrual to date
365
Final
Recruitment outside Australia
Country [1] 21337 0
Sweden
State/province [1] 21337 0
Stockholm

Funding & Sponsors
Funding source category [1] 302190 0
Hospital
Name [1] 302190 0
Department of Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital
Country [1] 302190 0
Sweden
Primary sponsor type
Hospital
Name
Department of Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital
Address
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
Eugeniavägen 23.
S3:03 Norrbacka
S-17176 Stockholm
Sweden
Country
Sweden
Secondary sponsor category [1] 302032 0
None
Name [1] 302032 0
Address [1] 302032 0
Country [1] 302032 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302870 0
Swedish Ethical Review Authority
Ethics committee address [1] 302870 0
Etikprövningsmyndigheten
FE 111 20
838 82 Frösön
Sweden
Ethics committee country [1] 302870 0
Sweden
Date submitted for ethics approval [1] 302870 0
25/01/2019
Approval date [1] 302870 0
11/03/2019
Ethics approval number [1] 302870 0
Dnr: 2019-01153

Summary
Brief summary
European guidelines for intraoperative maintenance fluid recommend a near-isotonic solution containing 1-2.5 % glucose. In most European countries, a near-isotonic solution containing 2,5 % glucose is not available. This necessitates anesthetic personal to add extra sodium to the solution. This may be hazardous – risk of adding wrong electrolyte, risk of infection etc. On the other hand, a commercial near-isotonic 1 % glucose solution is available. However, there are limited safety data for the risk of developing hypoglycemia for infants when 1 % glucose are given intraoperatively. Furthermore, basic knowledge of intraoperatively glucose metabolism are lacking. This study will considerably strengthen safety data for using a 1 % glucose solution. In addition, the study will provide new information of intraoperative endogenous glucose production, energy production and importance of duration of fasting for glucose metabolism intraoperatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91674 0
Dr Urban Fläring
Address 91674 0
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
Eugeniavägen 23.
S3:03 Norrbacka
S-17176 Stockholm
Sweden
Country 91674 0
Sweden
Phone 91674 0
+46708763900
Fax 91674 0
Email 91674 0
[email protected]
Contact person for public queries
Name 91675 0
Dr Urban Fläring
Address 91675 0
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
Eugeniavägen 23.
S3:03 Norrbacka
S-17176 Stockholm
Sweden
Country 91675 0
Sweden
Phone 91675 0
+46708763900
Fax 91675 0
Email 91675 0
[email protected]
Contact person for scientific queries
Name 91676 0
Dr Urban Fläring
Address 91676 0
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
Eugeniavägen 23.
S3:03 Norrbacka
S-17176 Stockholm
Sweden
Country 91676 0
Sweden
Phone 91676 0
+46708763900
Fax 91676 0
Email 91676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age, diagnose, Glucose-, sodium- and ketone concentration if requested.
When will data be available (start and end dates)?
Data are planned to be available May 31th 2021.

End date will be May 31th 2022.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Approval by Principal Investigator. Contact via email address ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.