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

Sponsor

Suez Canal University (Other)

Overall Status

Completed

CT.gov ID

NCT04144465

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)	Drug: NORADRENALIN Drug: PHENYLEPHRINE	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Effect of Noradrenaline Infusuion Versus Phenyephrine Infusion in Improving Tissue Perfusion in HIPEC

Actual Study Start Date :

Nov 1, 2019

Actual Primary Completion Date :

Oct 30, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

SERUM LACTATE IN ABG [IMMEDIATELY POSTOPERATIVELY]
LANDMARK FOR TISSUE AND ORGAN PERFUSION

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

CANCER PATIENTS ENROLLED FOR HIPEC

Exclusion Criteria:

DRUG SENSITIVITY

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Suez Canal University	Ismailia		Egypt	41511

Sponsors and Collaborators

Suez Canal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abdelrhman Alshawadfy, Clinical professor, Suez Canal University

ClinicalTrials.gov Identifier:

NCT04144465

Other Study ID Numbers:

noradrenaline vs phenylephrine

First Posted:

Oct 30, 2019

Last Update Posted:

May 13, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2022