Implication of Fluid Strategies Upon Hepatic Outcome in Hepatobiliary Surgery
Implications of Variable Intraoperative Fluid Strategies Upon the Hepatic Outcome in Hepatobiliary Surgery
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
compare the effect of two different protocol of fluid therapy in patients undergoing elective hepatobiliary surgery under general anesthesia regarding hemodynamics and SGPT change pre- and postoperative.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2019
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2019
CompletedFirst Posted
Study publicly available on registry
April 23, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedApril 23, 2019
April 1, 2019
1 year
April 18, 2019
April 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
SGPT change pre- and postoperative
effects of different fluid strategies in change of SGBT level pre- and postoperative
preoperative and in the first and second day postoperative
Study Arms (2)
Group (R)
EXPERIMENTALRestrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).
Group (C)
EXPERIMENTALConservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).
Interventions
comparison of two intraoperative fluid strategies upon hepatic outcome in hepatobiliary surgery
Eligibility Criteria
You may qualify if:
- patients\>18 years old, undergoing elective hepatobiliary surgery under general anesthesia and American Society of Anesthesiologists grade II.
You may not qualify if:
- patient refusal. 2-psychiatric disorders. 3-pregnancy and lactation. 4-preexisting neurological dysfunction (history of cerebrovascular stroke CVS) 5-metastatic cancer. 6-Inflammatory bowel disease. 7-Diabetes mellitus. 8-Renal insufficiency (serum creatinine level more than 180 μmol/l). 9- unexpected intraoperative findings (inoperable). 10-accidental massive intraoperative hemorrhage.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emad Zarief, assistant professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- specialist
Study Record Dates
First Submitted
April 18, 2019
First Posted
April 23, 2019
Study Start
October 1, 2019
Primary Completion
October 1, 2020
Study Completion
October 1, 2021
Last Updated
April 23, 2019
Record last verified: 2019-04