- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04144465
Noradrenaline Infusion Versus Phenylephrine Infusion in Improving Serum Lactate Level in HIPEC
May 9, 2022 updated by: Abdelrhman Alshawadfy, Suez Canal University
Effect of Noradrenaline Infusuion Versus Phenyephrine Infusion in Improving Tissue Perfusion in HIPEC
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
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ismailia, Egypt, 41511
- Suez Canal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- CANCER PATIENTS ENROLLED FOR HIPEC
Exclusion Criteria:
- DRUG SENSITIVITY
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: NORADRENALIN
NORADRENALINE INFUSION
|
DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION
Other Names:
|
ACTIVE_COMPARATOR: PHENYLEPHRINE
PHENYLEPHRINE INFUSION
|
DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SERUM LACTATE IN ABG
Time Frame: IMMEDIATELY POSTOPERATIVELY
|
LANDMARK FOR TISSUE AND ORGAN PERFUSION
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IMMEDIATELY POSTOPERATIVELY
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2019
Primary Completion (ACTUAL)
October 30, 2020
Study Completion (ACTUAL)
December 30, 2020
Study Registration Dates
First Submitted
October 19, 2019
First Submitted That Met QC Criteria
October 29, 2019
First Posted (ACTUAL)
October 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 13, 2022
Last Update Submitted That Met QC Criteria
May 9, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Body Temperature Changes
- Heat Stress Disorders
- Hyperthermia
- Fever
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Norepinephrine
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- noradrenaline vs phenylephrine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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