Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001395426
Ethics application status
Approved
Date submitted
6/09/2016
Date registered
7/10/2016
Date last updated
31/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The changes in serum potassium and blood sugar levels during heart surgery
Scientific title
Trend of changes in the intraoperative blood glucose and serum potassium levels of adult patients undergoing Off-Pump Coronary Artery Bypass surgeries
Secondary ID [1] 290106 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart surgery 300200 0
Condition category
Condition code
Anaesthesiology 300082 300082 0 0
Other anaesthesiology
Cardiovascular 300083 300083 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
36 adult patients of either sex undergoing elective off pump coronary bypass surgery (OPCAB) in Safdarjung hospital, New Delhi, India will be enrolled in this study. In the operation theatre, Etomidate/ Morphine ( 0.1 mg/kg) / Fentanyl (2 ug/kg) / vecuronium bromide (0.1mg/kg)/Oxygen/ Air will be used to induce anesthesia. Anesthesia will be maintained using oxygen/ air/ isoflurane and topups of vecuronium and morphine. Arterial blood gas analysis will be done by the staff anesthesiologist at predetermined intra-operative time points to measure levels of blood glucose and serum potassium as primary variables. Base excess, pH and HCO3? will be recorded as secondary variables. The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min at 30 min ( T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft ( T6) and end of surgery (T7). Insulin infusion will be started according to the sliding scale, whenever blood glucose will be higher than 200 mg/dl. Potassium Chloride 5 ml will be supplemented whenever serum potassium will be lower than 4mEq/l.
Intervention code [1] 295979 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299559 0
blood sugar levels will be measured intraoperatively at regular intervals
Timepoint [1] 299559 0
The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ---at 30 min ( T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7).
Primary outcome [2] 299727 0
serum potassium levels will be measured intraoperatively at regular intervals
Timepoint [2] 299727 0
The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ---at 30 min ( T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7).
Secondary outcome [1] 327507 0
serum pH variation with time will be measured intraoperatively
Timepoint [1] 327507 0
The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ----at 30 min (T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7).
Secondary outcome [2] 327950 0
serum HCO3 variation with time will be measured intraoperatively
Timepoint [2] 327950 0
The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ----at 30 min (T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7).
Secondary outcome [3] 327951 0
serum base excess levels will be measured intraoperatively
Timepoint [3] 327951 0
The time intervals will be just after arterial cannulation (T0), just before grafting (T1), thereafter, every 30 min ----at 30 min (T2), 60 min (T3), 90 min (T4), 120 min (T5), end of graft (T6) and end of surgery (T7).

Eligibility
Key inclusion criteria
Patients of either sex, undergoing CABG
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any liver/ renal abnormality

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/10/2016
Actual
14/10/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
28/02/2017
Date of last data collection
Anticipated
Actual
3/03/2017
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 8206 0
India
State/province [1] 8206 0
delhi

Funding & Sponsors
Funding source category [1] 294474 0
Hospital
Name [1] 294474 0
safdarjung hospital
Country [1] 294474 0
India
Primary sponsor type
Hospital
Name
safdarjung hospital
Address
Safdarjung hospital,Ring road, New Delhi, Delhi, India- 110029
Country
India
Secondary sponsor category [1] 293345 0
None
Name [1] 293345 0
Address [1] 293345 0
Country [1] 293345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295912 0
vardhaman mahavir medical college & safdarjung hospital ethics committee
Ethics committee address [1] 295912 0
Ethics committee country [1] 295912 0
India
Date submitted for ethics approval [1] 295912 0
08/02/2016
Approval date [1] 295912 0
16/05/2016
Ethics approval number [1] 295912 0
IEC -596

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68878 0
A/Prof kapil gupta
Address 68878 0
Associate professor, department of anesthesia
vardhaman mahavir medical college & safdarjung hospital,
Ring Road,New delhi,
Delhi,
India- 110029
Country 68878 0
India
Phone 68878 0
+91-9811859019
Fax 68878 0
Email 68878 0
[email protected]
Contact person for public queries
Name 68879 0
kapil gupta
Address 68879 0
Associate professor, department of anesthesia
vardhaman mahavir medical college & safdarjung hospital,
Ring Road,New delhi,
Delhi,
India- 110029
Country 68879 0
India
Phone 68879 0
+91-9811859019
Fax 68879 0
Email 68879 0
[email protected]
Contact person for scientific queries
Name 68880 0
kapil gupta
Address 68880 0
Associate professor, department of anesthesia
vardhaman mahavir medical college & safdarjung hospital,
Ring Road,New delhi,
Delhi,
India- 110029
Country 68880 0
India
Phone 68880 0
+91-9811859019
Fax 68880 0
Email 68880 0
[email protected]

No information has been provided regarding IPD availability


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.