Trial no.:	PACTR202012816670352	Date of Approval:	25/12/2020
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Goal directed fluid therapy in major hepatic resection surgeries, a prospective randomized study

Official scientific title

fluid therapy in major hepatectomy

Brief summary describing the background and objectives of the trial

Major liver resection is a complex procedure with a high incidence of perioperative complications, even in high volume centres. Optimization of perfusion and oxygen delivery to the residual liver and other organs, whilst avoiding hyper and hypovolemia, remain the cornerstones of best hemodynamic care and is associated with reduced intraoperative bleeding, perioperative complications and hospital length of stay. Traditionally, fluid intervention for major hepatic resection includes fluid restriction and low central venous pressure during the dissection and transection phases to reduce venous bleeding, with restoration of euvolemia post transection with judicious fluid intervention. However, restrictive fluid regimen was not associated with a higher rate of dis- ability-free survival than a liberal fluid regimen and was associated with a higher rate of acute kidney injury1–3. In the context of fluid management, the importance of the prediction of fluid responsiveness (FR) relies on the fact that the fluid loading in such condition may be hazardous and dangerous for the patient, e.g., by causing or worsening pulmonary edema. Moreover, the fluid management of cirrhotic patients undergoing orthotopic liver transplantation (OLT) may be challenging and still remains controversial. The expected response to fluid infusion is an increase of cardiac output (CO) or stroke volume (SV), and this response depends mostly on the position of an individual patient on the cardiac function curve, i.e., the Frank-Starling curve4–6. Many indices have been proposed to predict FR, which are considered related to the Frank-Starling curve and a sort of an estimation of curve slope, i.e., the so-called dynamic indices (pulse pressure variation (PPV), stroke volume variation (SVV), and systolic pressure variation (SPV). However, these studies mainly concern ICU settings, septic, or postoperative patients7–9. In this study, we will compare the intraoperative goal directed fluid therapy in hepatic surgery, directed by systolic pressure variability, versus traditional low CVP approach. The primary objective will be the impact of GDT on patient outcome presented as length of hospital stay. Secondary variables will be the intraoperative fluid infusion, the need for vasopressors, perioperative end-organ function (kidney, liver, and brain), intraoperative tissue perfusion, perioperative electrolyte disturbances.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Anaesthesia,Surgery

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Prevention

Anticipated trial start date

20/12/2020

Actual trial start date

Anticipated date of last follow up

20/04/2021

Actual Last follow-up date

Anticipated target sample size (number of participants)

90

Actual target sample size (number of participants)

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table created by a computer software program	Sealed opaque envelopes	Masking/blinding used	Care giver/Provider,Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	S group	hemodynamic and fluid management will be guided by SPV o be kept less than 14 during the dissection and hepatectomy phase.	hemodynamic and fluid management will be guided by SPV o be kept less than 14 during the dissection and hepatectomy phase.	hemodynamic and fluid management will be guided by SPV o be kept less than 14 during the dissection and hepatectomy phase.	45
Control Group	C group	Fluid and hemodynamic management will be guided by CVP measurement to be kept less than 5 cmH2o	Fluid and hemodynamic management will be guided by CVP measurement to be kept less than 5 cmH2o	Fluid and hemodynamic management will be guided by CVP measurement to be kept less than 5 cmH2o	45	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
The study population will include all patients scheduled for hepatic resection, Age range from 18- to 60-year, the following surgical categories will be included: ‘excision of lesion of liver’, ‘segmental resection of liver’, ‘lobectomy of liver’, ‘trisegmental resection of liver’, Right hepatectomy (segments V-VIII) or extended right hepatectomy (segments IV-VIII).	Exclusion criteria will include: lack of written consent, drug abuse, preoperative renal dysfunction, BMI >40, and coagulopathies.	Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	65 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

05/12/2020

Institutional Research Board

Ethics Committee Address
Street address	City	Postal code	Country
Elgomhoareya	Mansoura	35516	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	hospital length of stay	Time days for atent to be discharged from hospital after day of surgery
Secondary Outcome	the need for vasopressors	during the perioperative period

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
MAnsoura University hospitals	Elgomhoreya street	Mansoura		Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Mansoura university	Elgomhoreya	Mansoura		Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Mansoura University	Elgomhoreya	Mansoura		Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Amgad Zaghloul	Geihan street	Mansoura		Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Alreafey Alrefaey	refa3ey2@yahoo.com	00201064203475	Geihan street
City	Postal code	Country	Position/Affiliation
Mansoura		Egypt	Mansoura University
Role	Name	Email	Phone	Street address
Public Enquiries	Alrefaey Alrefaey	refa3ey2@yahoo.com	00201064203475	Geihan street
City	Postal code	Country	Position/Affiliation
Mansoura		Egypt	Mansoura university
Role	Name	Email	Phone	Street address
Scientific Enquiries	Alrefaey Alrefaey	refa3ey2@yahoo.com	00201064203475	Geihan street
City	Postal code	Country	Position/Affiliation
Mansoura		Egypt	Mansoura university

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	planning to share the study protocol, results table within 6 month after completion of the research	Informed Consent Form,Statistical Analysis Plan,Study Protocol	within 6 month after completion of the research	ay individual or institutional request covered by an appropriate ethical committee
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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