Noradrenaline Infusion Versus Phenylephrine Infusion in I... | NCT04144465

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

NCT04144465

Sponsor

Suez Canal University

Status

Completed

Last Update Posted

May 29, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Interventions

NORADRENALIN
PHENYLEPHRINE

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Oct 30, 2023Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Oct 19, 2019

First Submission Date that Met QC Criteria

Oct 29, 2019

First Posted Date

Oct 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2024

Last Update Posted Date

May 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NORADRENALIN	Active Comparator	NORADRENALINE INFUSION	Drug: NORADRENALIN
PHENYLEPHRINE	Active Comparator	PHENYLEPHRINE INFUSION	Drug: PHENYLEPHRINE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NORADRENALIN	Drug	DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION	NORADRENALIN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SERUM LACTATE IN ABG	LANDMARK FOR TISSUE AND ORGAN PERFUSION	IMMEDIATELY POSTOPERATIVELY

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CANCER PATIENTS ENROLLED FOR HIPEC

Exclusion Criteria:

DRUG SENSITIVITY

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suez Canal University		Ismailia		41511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010477	Perfusion
D010656	Phenylephrine

Ancestor Terms

ID	Term
D008919	Investigative Techniques
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided