Transesophageal Echocardiology Measured Left Ventricular End Diastolic Area as Guide for Administering Goal Directed Fluids During Major Oncosurgeries (TEE LVEDA)
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|ClinicalTrials.gov Identifier: NCT03853031|
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : October 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Goal Directed Fluid Therapy||Procedure: LVEDA cm2 guided intraoperative fluid in TEE /Study Group Procedure: CVP guided intraoperative fluid in CVP / Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||During surgery Control group of patients will receive CVP guided fluids Study group of patients will receive TEE measured LVEDA guided fluids|
|Masking Description:||Patients will be randomly allotted to either TEE or CVP Group according to computer generated randomization thus will be masked .|
|Official Title:||Transesophageal Echocardiology Measured Left Ventricular End Diastolic Area (LVEDA) as Guide for Intraoperative Goal Directed Fluid Therapy (GDFT) in Major Oncosurgeries|
|Actual Study Start Date :||April 6, 2019|
|Actual Primary Completion Date :||September 30, 2019|
|Actual Study Completion Date :||October 10, 2019|
Active Comparator: LVEDA guided intraoperative fluid therapy
Patients in TEE group will be given crystalloid fluids during surgery guided by LVEDA cm2 to be maintained between 10 -18 cm2 , if LVEDA < 10 cm2 then 200ml colloid bolus will be given and increase in LVEDA noted.
Procedure: LVEDA cm2 guided intraoperative fluid in TEE /Study Group
Placement of Transoesophageal echocardiography probe in TEE group to measure Left ventricular end diastolic area cm2
Active Comparator: CVP guided intraoperative fluid therapy
Patients in CVP group will be given crystalloid fluids during surgery guided by CVP values to be maintained between 10 -16 cms of water H2O ,if CVP value < 10 cms H2O then 200 ml colloid bolus will be given and increase in CVP value noted.
Procedure: CVP guided intraoperative fluid in CVP / Control group
Ultrasound guided Internal Jugular Vein catheter placement in CVP group to measure CVP value cms H2O .
- To calculate total intraoperative fluids required in TEE (study) and CVP (control) group in litres. [ Time Frame: Upto 8 hours ]During the surgery Study group will receive fluids ( crystalloids and bolus colloids) guided by LVEDA cm2 and Control group will receive fluids (crystalloids and bolus colloids) guided by CVP cms H20
- To compare serum lactate levels in millimols/litre [ Time Frame: upto 48 hours ]In both the groups through completion of surgery and at postoperative 24 hours and postoperative 48 hours serum lactate levels will be measured .
- To compare serum creatinine in milligrams per decilitre in both the groups [ Time Frame: Upto 48 hours. ]In both groups serum creatinine in milligrams per decilitre will be measured at postoperative 24 and postoperative 48 hours.
- Length of ICU stay [ Time Frame: Upto 10 days ]In both the groups postoperative stay in the ICU will be noted in days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853031
|Delhi, India, 110085|
|Principal Investigator:||Anita Kulkarni, MD||Rajiv Gandhi Cancer Institute & Research Centre , India|
|Principal Investigator:||Anita Kulkarni, M.D.||Rajiv Gandhi Cancer Institute & Research Centre , India|