Temporary portocaval Shunt during recipient hepatectomy improves intra operative parameters and morbidity in LDLT recipients
All patients satisfying the inclusion criteria, written informed consent will be taken and patients are randomized into intervention group ( Portocaval Shunt Group) and Non intervention group ( No Shunt Group).Patients from both the groups will be assessed for Hemodynamic parameters, Urine Output, Blood loss, blood products requirement , Duration of surgery during the procedure. They will be assessed for renal function, presence of sepsis, Morbidity, early graft dysfunction, ICU stay and total hospital stay in the post operative period.All patients will be followed up till discharge from hospital.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
In Temorary Portocaval Shunt Group (TPCS group), Hilar dissection( division of Hepatic artery, Bileduct) is followed by temporary portocaval shunt formation during recipient Hepatectomy.
Blood Pressure between two groups at fixed time points
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg
Time frame: T0- At the beginning of the procedure
Ionotropes requirement between two groups at fixed time points
Noradrenaline and Vasopressin requirement in milliliter/hour
Time frame: T0- At the beginning of the procedure
Lactate level between two groups at fixed time points
Lactate levels are documented from Arterial Blood Gas analysis
Time frame: T0- At the beginning of the procedure
Blood Pressure between two groups at fixed time points
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg
Time frame: T1- During procedure- Before portocaval shunt formation
Ionotropes requirement between two groups at fixed time points
Noradrenaline and Vasopressin requirement in milliliter/hour
Time frame: T1- During procedure- Before portocaval shunt formation
Lactate level between two groups at fixed time points
Lactate levels are documented from Arterial Blood Gas analysis
Time frame: T1- During procedure- Before portocaval shunt formation
Blood Pressure between two groups at fixed time points
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
Time frame: T2- During procedure- Just Before Reperfusion of graft liver
Ionotropes requirement between two groups at fixed time points
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Noradrenaline and Vasopressin requirement in milliliter/hour
Time frame: T2- During procedure- Just Before Reperfusion of graft liver
Lactate level between two groups at fixed time points
Lactate levels are documented from Arterial Blood Gas analysis
Time frame: T2- During procedure- Just Before Reperfusion of graft liver
Blood Pressure between two groups at fixed time points
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
Time frame: T3- During procedure- 5 minutes after reperfusion of graft liver
Ionotropes requirement between two groups at fixed time points
Noradrenaline and Vasopressin requirement in milliliter/hour
Time frame: T3- During procedure- 5 minutes after reperfusion of graft liver
Lactate level between two groups at fixed time points
Lactate levels are documented from Arterial Blood Gas analysis
Time frame: T3- During procedure- 5 minutes after reperfusion of graft liver
Blood Pressure between two groups at fixed time points
Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg
Time frame: T4- During procedure- Before closure of abdomen
Ionotropes requirement between two groups at fixed time points
Noradrenaline and Vasopressin requirement in milliliter/hour
Time frame: T4- During procedure- Before closure of abdomen
Lactate level between two groups at fixed time points
Lactate levels are documented from Arterial Blood Gas analysis
Time frame: T4- During procedure- Before closure of abdomen
Blood loss between two groups during intraoperative period
Blood loss during the procedure is measured in milliliter
Time frame: During Procedure
Duration of surgery between two groups.
Duration between incision time to closure of abdomen is noted in minutes
Time frame: During Procedure
Increase in creatinine levels of Increase 1.5-1.9 times from baseline in the post op period.
Serum Creatinine is measured in milligram per deciliter
Time frame: Number of days post transplantation procedure (upto 45 days)
≥0.3 mg/dl increase within 48 h or Urine output < 0.5 ml/kg/h for 6-12 h in the post op period.
Serum Creatinine is measured in milligram per deciliter
Time frame: Number of days post transplantation procedure (upto 45 days)
Urine output between two groups
Urine output during the transplantation procedure is measured in milliliter
Time frame: During Transplantation procedure
To compare tolerance to enteral feed between two groups
Tolerance to NG feed is defined by absence of bloating, nausea, vomiting, abdominal distention or ileus
Time frame: Number of days post transplantation procedure (upto 45 days)
Endotoxin levels
Serum endotoxin levels increases in cases of bowel congestion and hemodynamic instability when portal vein is clamped during recipient hepatectomy
Time frame: Levels of Serum endotoxin levels in pre op and 12 hours after surgery
Number of patients with Early allograft dysfunction
Early allograft dysfunction using criteria defined - total bilirubin \>10 mg/dL, INR \>1.6 and serum urea \>100 mg/dL, for five consecutive days after day 7
Time frame: For 5 consecutive days after day 7
Incidence of Morbidity
Morbidity is defined by Clavein Dindo Classification - \>/=3. Sepsis as defined by Sepsis- 3 criteria, presence of 2 or more of the following 1.altered mentation, 2.respiratory rate ≥22 breaths/min 3.systolic blood pressure ≤100 mm Hg
Time frame: Number of days post transplantation procedure (upto 45 days)
Incidence of sepsis
Morbidity is defined by Clavein Dindo Classification - \>/=3. Sepsis as defined by Sepsis- 3 criteria, presence of 2 or more of the following 1.altered mentation, 2.respiratory rate ≥22 breaths/min 3.systolic blood pressure ≤100 mm Hg
Time frame: Number of days post transplantation procedure (upto 45 days)
Number of days of ICU stay
Day patient shifted from ICU to ward is documented as total ICU stay. Day patient is discharged from hospital is documented for total hospital stay
Time frame: Number of days post transplantation procedure (upto 45 days)
Number of days of hospital stay
Day patient shifted from ICU to ward is documented as total ICU stay. Day patient is discharged from hospital is documented for total hospital stay
Time frame: Number of days post transplantation procedure (upto 45 days)