Noradrenaline Infusion Versus Phenylephrine Infusion in Improving Serum Lactate Level in HIPEC

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
• Conditions: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
• Intervention / Treatment: Drug: NORADRENALIN; Drug: PHENYLEPHRINE

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

Study Locations

• Egypt
  • Ismailia, Egypt, 41511
    • Suez Canal University

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: NORADRENALIN; NORADRENALINE INFUSION	Drug: NORADRENALIN; DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION; Other Names: PERFUSION
ACTIVE_COMPARATOR: PHENYLEPHRINE; PHENYLEPHRINE INFUSION	Drug: PHENYLEPHRINE; 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	LANDMARK FOR TISSUE AND ORGAN PERFUSION	IMMEDIATELY POSTOPERATIVELY

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

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