Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616001395426 |
Date of registration:
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07/10/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The changes in serum potassium and blood sugar levels during heart surgery
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Scientific title:
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Trend of changes in the intraoperative blood glucose and serum potassium levels of adult patients undergoing Off-Pump Coronary Artery Bypass surgeries |
Date of first enrolment:
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14/10/2016 |
Target sample size:
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36 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616001395426.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Non-randomised trial;
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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A/Prof kapil gupta
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Address:
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Associate professor, department of anesthesia
vardhaman mahavir medical college & safdarjung hospital,
Ring Road,New delhi,
Delhi,
India- 110029
India |
Telephone:
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+91-9811859019 |
Email:
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kapgup11@yahoo.co.in |
Affiliation:
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Name:
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A/Prof kapil gupta
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Address:
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Associate professor, department of anesthesia
vardhaman mahavir medical college & safdarjung hospital,
Ring Road,New delhi,
Delhi,
India- 110029
India |
Telephone:
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+91-9811859019 |
Email:
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kapgup11@yahoo.co.in |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients of either sex, undergoing CABG
Exclusion criteria: Any liver/ renal abnormality
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Anaesthesiology - Other anaesthesiology
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Cardiovascular - Coronary heart disease
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heart surgery; heart surgery
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Intervention(s)
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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.
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Primary Outcome(s)
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blood sugar levels will be measured intraoperatively at regular intervals[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). ]
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serum potassium levels will be measured intraoperatively at regular intervals[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). ]
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Secondary Outcome(s)
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serum base excess levels will be measured intraoperatively[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). ]
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serum HCO3 variation with time will be measured intraoperatively[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). ]
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serum pH variation with time will be measured intraoperatively [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). ]
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Source(s) of Monetary Support
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safdarjung hospital
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Ethics review
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Status: Approved
Approval date:
Contact:
vardhaman mahavir medical college & safdarjung hospital ethics committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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