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Trial record 61 of 81593 for:    measured

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
Sponsor:
Information provided by (Responsible Party):
Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India

Brief Summary:
Intraoperative fluid management is pivotal to successful outcome of major oncosurgeries . Adequate volume replacement to achieve optimal cardiac performance is critical to prevent any deleterious consequences of under resuscitation or fluid overload . Traditionally CVP monitoring has been tool to guide intraoperative fluid therapy and has poor reliability as indicator of volume status . Transesophageal Echocardiography measured LVEDA is more reliable and sensitive measure of left ventricular volume to guide intraoperative fluid therapy . Investigators plan the study comparing total fluid requirement and postoperative outcomes in two groups of patients receiving central venous pressure (CVP) guided and Left ventricular end diastolic area( LVEDA) guided fluids for major oncosurgeries.

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

Detailed Description:
Adult patients undergoing major oncosurgeries will be included in the study ,with Alpha Error(%) = 5 ,Power(%)= 80 ,required sample size per group is 29.Investigators will include 30 patients in each group. Patients will be randomly allotted to Central Venous Pressure CVP Group (Control Group) or Transesophageal Echocardiography TEE Group (Study Group) according to computer generated randomization. In the OR 5 lead Electrocardiogram ( ECG ), Oxygen saturation (SPO2 ), Noninvasive blood Pressure (NIBP) , End tidal carbon di oxide (ETCO2 )monitors will be attached .Under local anesthesia 16Gauge peripheral intravenous and Radial artery cannulation will be performed . Anesthesia will be induced with Fentanyl 1mcg/kg-1, Morphine 0.05mg/kg-1, Propofol titrated dosage 1-2 mg/kg-1 and neuromuscular blockade with Atracurium 0.5mg/kg-1.Trachea will be intubated with oral cuffed endotracheal tube of appropriate size. Anaesthesia will be maintained with O2 / Air mixture 40:60 % Intermittent Positive Pressure Ventilation with Sevoflurane , intermittent boluses of Fentanyl and Train of Four ratio guided Atracurium . Postintubation ultrasound guided internal jugular vein will be cannulated with B.Braun 7French 20cm, 16 G Triple lumen central venous catheter in CVP Group patients . ESAOTE TEE 022 multiplane probe will be placed in TEE Group patients.Intraoperative all patients will be given one-third starvation fluid in first hour of surgery , maintenance fluid 2ml/hour crystalloid . Goal is to maintain CVP between 10 -16 cms of water (H20) in CVP Group , values will be recorded every 30 minutes if CVP decreases < 10 then 200 ml colloid bolus will be given and increase in CVP value noted . In the TEE Group TEE probe will be inserted in the oesophagus (40-45 cms) adjusted to obtain mid-papillary transgastric short axis view ,the desired view will be freezed at end-diastole and the left ventricular cavity will be traced including the papillary muscles to obtain left ventricular end diastolic area in cm2 , the average of three readings at particular interval will be noted . Every half hourly values will be measured and also if systolic blood pressure < 90 mm Hg . Fluid therapy will be given with the aim to maintain LVEDA ≥ 10 cm2 (ranging between 10-18 cm2). For readings < 10 cm2 colloid bolus 200 ml will be given and increase in the LVEDA will be noted.Urine output will be recorded every 30 minutes in all the patients. Titrated noradrenaline infusion (conc 0.08mg/ml ) will be started if Mean Arterial Pressure (MAP) < 70 mmHg with optimal fluid administration in CVP and TEE group .Serum lactate levels will be measured on completion of surgery and postoperative at 24 and 48 hours.On completion of surgery in the study group TEE probe will be removed and ultrasound guided internal jugular vein cannulation will be performed with 7French 16 G cannula for administering CVP guided fluid in the Postoperative Anaesthesia care unit (PACU) neuromuscular blockade will be reversed and trachea extubated . In PACU both groups will receive CVP guided intravenous fluids , monitoring will include heart rate , Blood Pressure ,SPO2 , CVP , urine output . Note will be made of any patient requiring postoperative ventilator support , inotropic support ,return of bowel sounds, serum lactate levels and serum creatinine levels at 24 and 48 hours and length of ICU stay.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
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: Single (Participant)
Masking Description: Patients will be randomly allotted to either TEE or CVP Group according to computer generated randomization thus will be masked .
Primary Purpose: Treatment
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

Arm Intervention/treatment
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 .




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 .

  2. 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.

  3. Length of ICU stay [ Time Frame: Upto 10 days ]
    In both the groups postoperative stay in the ICU will be noted in days.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing major abdominopelvic oncosurgeries .

Exclusion Criteria:

  • oesophageal varices
  • carcinoma oesophagus
  • carcinoma stomach
  • coagulopathies
  • duration of surgery exceeding 8 hours.

Information from the National Library of Medicine

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


Locations
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India
Anita Kulkarni
Delhi, India, 110085
Sponsors and Collaborators
Rajiv Gandhi Cancer Institute & Research Center, India
Investigators
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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

Publications:
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Responsible Party: Dr Anita Kulkarni, Principal Investigator, Rajiv Gandhi Cancer Institute & Research Center, India
ClinicalTrials.gov Identifier: NCT03853031     History of Changes
Other Study ID Numbers: RGCIRC Rohini
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India:
TEE
LVEDA
CVP
GDFT