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Trial registered on ANZCTR


Registration number
ACTRN12615001304527
Ethics application status
Approved
Date submitted
12/10/2015
Date registered
30/11/2015
Date last updated
8/02/2022
Date data sharing statement initially provided
8/02/2022
Date results information initially provided
8/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Sedation Practice in Paediatric Intensive Care Cardiac Patients: Cardiac Baby SPICE -pilot randomised trial
Scientific title
In children requiring surgical repair of congenital cardiac defects, does the use of Dexmedetomidine as the primary sedative agent compared to Midazolam reduce the length of mechanical ventilation and PICU length of stay.
Secondary ID [1] 286954 0
Nil
Universal Trial Number (UTN)
Trial acronym
Cardiac Baby SPICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital cardiac defects requiring surgical repair 295405 0
Condition category
Condition code
Cardiovascular 295662 295662 0 0
Diseases of the vasculature and circulation including the lymphatic system
Anaesthesiology 296780 296780 0 0
Anaesthetics
Surgery 296781 296781 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous infusion of Dexmedetomidine 1mcg/kg/hr commenced at sternotomy for the duration of the surgical procedure and during mechanical ventilation in the paediatric intensive care.
Intervention code [1] 292154 0
Treatment: Drugs
Comparator / control treatment
Intravenous infusion of Midazolam 80mcg/kg/hr commenced at sternotomy for the duration of the surgical procedure and during mechanical ventilation in the paediatric intensive care.
Control group
Active

Outcomes
Primary outcome [1] 296215 0
To evaluate the feasibility of screening and recruiting patients prior to cardiac surgery, Assessed of feasibility by proportion of screened and eligible patients who were recruited, protocol fidelity, proportion of enrolled patients who were intubated for longer than 24 hours, duration from time of intubation to time of randomisation and time from randomisation to time of commencement of study medications, retention of subjects to 90 day follow-up
Timepoint [1] 296215 0
At completion of 12mth patient study period
Secondary outcome [1] 317851 0
To assess the process of delivering an intervention that uses dexmedetomidine as the primary sedative agent prior to placement on cardiopulmonary bypass, and early in the ICU admission, and that minimises the use of benzodiazepines. This will be assessed via daily calculation of total use dexmedetomidine
Timepoint [1] 317851 0
After all participants have been recruited
Secondary outcome [2] 317853 0
To measure separation between the midazolam group and the demedetomidine group with respect to administered doses of sedative and analgesic drugs. The total cumulative and total daily dose of dexmedetomidine, midazolam, propofol, clonidine, ketamine, fentanyl, morphine and other sedatives assessed by review of hospital records.
Timepoint [2] 317853 0
At discharge from PICU
Secondary outcome [3] 317854 0
To further assess the safety of delivering an intervention that uses dexmedetomidine as the primary sedative agent prior to placement on cardiopulmonary bypass, and early in the ICU admission assessed via adverse events reported on case report forms. It is recognised that the paediatric intensive care patient population will experience a number of common aberrations in laboratory values, signs and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an adverse event unless they require significant intervention or are considered to be of concern in the investigator’s clinical judgement.

Adverse events
Unplanned extubation assessed by review of hospital chart
Unplanned removal of vascular lines assessed by review of hospital chart
Re-intubation assessed by review of hospital chart

Adverse drug effects
Bradycardia (< 2 standard deviations below mean for age) assessed by EEG
Hypotension (< 2 standard deviations below mean for age) assessed by IAL BP or non-invasive BP
Drug withdrawal syndromes assessed by WAT-1 assessment
Timepoint [3] 317854 0
Safety will be monitored throughout admission to PICU and assessed at discharge from PICU.
Secondary outcome [4] 317855 0
Length of mechanical ventilation during PICU admission assessed by review of hospital records. .
Timepoint [4] 317855 0
At PICU discharge
Secondary outcome [5] 317856 0
To compare level of sedation achieved between intervention and control groups using the State Behavioural Scale. 2. The proportion of patients in SBS categories -2 to -3 (deep sedation), -1 to +1 (light sedation) and +2, assessed every day in ventilated patients still receiving sedative infusions.
Timepoint [5] 317856 0
This will be assessed a 6 time intervals per day during PICU admission until PICU discharge
Secondary outcome [6] 317858 0
Incidence of unplanned extubation assessed by review of hospital record.
Timepoint [6] 317858 0
This will be assessed at discharge from PICU
Secondary outcome [7] 318514 0
Length of stay in PICU assessed by review of hospital record.
Timepoint [7] 318514 0
At PICU discharge
Secondary outcome [8] 318515 0
To compare incidence of neurodevelopmental delay using Bayley III
Timepoint [8] 318515 0
At 12 months post PICU admission.
Secondary outcome [9] 318516 0
To compare incidence of new morbidities using Ages and Stages Questionnaire
Timepoint [9] 318516 0
At 6 & 12 months post PICU admission
Secondary outcome [10] 318517 0
To compare incidence of Health Related Quality of Life using the PEDS-Qual
Timepoint [10] 318517 0
At 6 and 12 month post PICU
Secondary outcome [11] 318518 0
Incidence of unplanned removal of vascular lines assessed by review of hospital record.
Timepoint [11] 318518 0
This will be assessed at discharge from PICU
Secondary outcome [12] 351416 0
To evaluate the impact of sedation on sleep patterns and variations.
Measured with actigraphy, Brief Infant Sleep Questionnaire (BISQ) and sleep diary.
Timepoint [12] 351416 0
Hospital discharge, 6 months and 12 months

Eligibility
Key inclusion criteria
1. The patient is undergoing surgical repair of a congenital heart defect requiring cardiopulmonary bypass and will require mechanical ventilation via an endotracheal tube post-operatively, and the treating clinician believes that:
2. The patient will require immediate post-operative AND ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures.
3. The patient is expected to remain intubated post-operatively.
Minimum age
No limit
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age > 12 months
2. Proven or suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, intracranial infection or hypoxic brain injury.
3. Allergy to dexmedetomidine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised prior to theatre using Web based randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done in permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a feasibility trial of 2 randomised sedative interventions used in critically ill patients, with the primary outcome being the difference in the proportion of time patients successfully achieve light sedation in the first 48 hours of sedation in intensive care in each arm. A sample size of 66 subjects will be sufficient to show a reduction of at least 25% in the cumulative sedation score in the intervention arm as compared to the standard arm, in the first 48 hours, and allow meaningful assessment of important secondary outcomes. The cumulative sedation score will be a continuous variable between 0 and 12 and a t-test to compare the mean cumulative sedation score in each group. Means with standard deviation for normally distributed variables and medians with interquartile ranges for non-normally distributed continuous variables, and proportions with 95% confidence limits, will be reported. If feasible, a logistic regression analysis will be used to identify factors such as site or patient characteristics that are associated with a particular pattern of sedation or clinical practice, such as deviation from the targeted level of sedation or inappropriate ‘deep’ sedation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2016
Actual
10/04/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
31/10/2019
Date of last data collection
Anticipated
31/12/2019
Actual
30/12/2020
Sample size
Target
66
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4445 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 10652 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 292204 0
Hospital
Name [1] 292204 0
Lady CIlento Children's Hospital
Country [1] 292204 0
Australia
Funding source category [2] 300568 0
Commercial sector/Industry
Name [2] 300568 0
Investigator Initiated Grant, Pfizer Essential Healthcare
Country [2] 300568 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Paediatic Critical Care Research Group
Address
PCCRG
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 290880 0
None
Name [1] 290880 0
None
Address [1] 290880 0
None
Country [1] 290880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293675 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 293675 0
Children’s Health Queensland Human Research Ethics Committee
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 293675 0
Australia
Date submitted for ethics approval [1] 293675 0
20/06/2015
Approval date [1] 293675 0
27/08/2015
Ethics approval number [1] 293675 0
HREC/15/QRCH/119

Summary
Brief summary
Intravenous sedatives and analgesics are commonly administered to mechanically ventilated children post cardiac surgery, however there is substantial variability in sedation practices in different intensive care units and in different countries around the world. The Cardiac BabySPICE pilot study will evaluate the hypothesis that early light sedation with dexmedetomidine reduces length of mechanical ventilation and length of stay in PICU compared to standard practice (midazolam). In addition we will follow up the neurodevelopment (at 6 and 12 months) of the included subjects; infants undergoing cardiac surgery on bypass <6 months of age. The purpose of the Cardiac BabySPICE Pilot RCT is to obtain preliminary data on the feasibility and safety of conducting a study that tests this hypothesis.

This is a pilot prospective randomised controlled trial that will be conducted in the Lady Cilento Children's Hospital paediatric intensive care unit in Australia and will recruit 60 patients. The study will recruit patients undergoing repair of congenital heart disease who require a breathing tube at least 24 hours after enrolment AND need immediate and ongoing sedation. Patients will be recruited into one of 2 study groups. The study drug will commence whilst the child is in surgery. The intervention arm will receive dexmedetomidine as the primary agent, with the addition of secondline sedatives as required by infusion, boluses or both. The use of benzodiazepines in this arm will be minimized and clonidine will not be used concurrently with dexmedetomidine. The control arm will have midazolam according to usual practice.In both groups, the default sedation level in PICU is light sedation, as defined by a target State Behaviour Scale (SBS) of 1 to +1, unless otherwise specified by the treating clinician. The primary outcome measure for the pilot study is to demonstrate separation between the intervention group (Dex) and the control group (Mid) with respect to the proportion of patients achieving light sedation (SBS 1 to +1) in the first 48 hours of sedation in intensive care.WE will also examine length of veniltation, PICU length of stay and long term outcomes. Information from the Pilot RCT will be used to design a subsequent phase III trial.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58266 0
Dr Debbie Long
Address 58266 0
PCCRG
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Country 58266 0
Australia
Phone 58266 0
+61(0)730681474
Fax 58266 0
Email 58266 0
[email protected]
Contact person for public queries
Name 58267 0
Dr Debbie Long
Address 58267 0
PCCRG
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Country 58267 0
Australia
Phone 58267 0
+61(0)730681474
Fax 58267 0
Email 58267 0
[email protected]
Contact person for scientific queries
Name 58268 0
Dr Debbie Long
Address 58268 0
PCCRG
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Country 58268 0
Australia
Phone 58268 0
+61(0)730681474
Fax 58268 0
Email 58268 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14981Study protocol  [email protected]
14982Informed consent form  [email protected]
14983Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.