Back to resultsNoradrenaline Infusion Versus Phenylephrine Infusion in Improving Serum Lactate Level in HIPEC
Primary Purpose
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
NORADRENALIN
PHENYLEPHRINE
Sponsored by
About this trial
This is an interventional treatment trial for Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Eligibility Criteria
Inclusion Criteria:
- CANCER PATIENTS ENROLLED FOR HIPEC
Exclusion Criteria:
- DRUG SENSITIVITY
Sites / Locations
- Suez Canal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NORADRENALIN
PHENYLEPHRINE
Arm Description
NORADRENALINE INFUSION
PHENYLEPHRINE INFUSION
Outcomes
Primary Outcome Measures
SERUM LACTATE IN ABG
LANDMARK FOR TISSUE AND ORGAN PERFUSION
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04144465
Brief Title
Noradrenaline Infusion Versus Phenylephrine Infusion in Improving Serum Lactate Level in HIPEC
Official Title
Effect of Noradrenaline Infusuion Versus Phenyephrine Infusion in Improving Tissue Perfusion in HIPEC
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
ABG PARAMETERS ARE CHANGED DURING HIPEC, WE TRIED TO FIND COMPARISON BETWEEN NORADRENALINE AND PHENYLEPHRINE IN OPTIMIZING ABG PARAMETERS THAT REFLECTS ORGAN PERFUSIONS ESPECIALLY SERUM LACTATE
Detailed Description
Arterial blood gas testing is considered one of the most important and widely used test in the detection of acidosis, alkalosis, electrolytes disturbance and tissue perfusion. in regard to tissue perfusion serum lactate above 4 mmol/L indicates poor tissue perfusion. serum lactate could be measured at ABG or separately. in this study we will test the effect of both noradrenaline and phenylephrine on lactate level at ABG during the stage of HIPAC in managing abdominal cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NORADRENALIN
Arm Type
Active Comparator
Arm Description
NORADRENALINE INFUSION
Arm Title
PHENYLEPHRINE
Arm Type
Active Comparator
Arm Description
PHENYLEPHRINE INFUSION
Intervention Type
Drug
Intervention Name(s)
NORADRENALIN
Other Intervention Name(s)
PERFUSION
Intervention Description
DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION
Intervention Type
Drug
Intervention Name(s)
PHENYLEPHRINE
Intervention Description
DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION
Primary Outcome Measure Information:
Title
SERUM LACTATE IN ABG
Description
LANDMARK FOR TISSUE AND ORGAN PERFUSION
Time Frame
IMMEDIATELY POSTOPERATIVELY
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CANCER PATIENTS ENROLLED FOR HIPEC
Exclusion Criteria:
DRUG SENSITIVITY
Facility Information:
Facility Name
Suez Canal University
City
Ismailia
ZIP/Postal Code
41511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Noradrenaline Infusion Versus Phenylephrine Infusion in Improving Serum Lactate Level in HIPEC
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