NCT05035303

Brief Summary

during PCNL; A few milliliters of nor-epinephrine is injected into the intended tract after puncture of pelvicalyceal system and before its dilatation compared to injection of saline (placebo). hemoglobin change \& blood loss is estimated and will compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

August 30, 2021

Last Update Submit

January 4, 2022

Conditions

Blood Loss, Surgical

Outcome Measures

Primary Outcomes (2)

  • hemoglobin drop

    the lower drop is better

    72 hours post intervention

  • blood loss

    the lower loss is better

    immediately after surgery

Secondary Outcomes (2)

  • stone free rate

    within 3 months post-operative

  • adverse events

    within 30 days post-operative

Study Arms (2)

Nor-Epinephrine (NE)-Group

ACTIVE COMPARATOR

The PCNL tract is infiltrated by Nor-Epinephrine before its dilatation.

Procedure: Nor-Epinephrine injection versus saline during PCNL

S-Group

PLACEBO COMPARATOR

The PCNL tract is infiltrated by Normal Saline before its dilatation.

Procedure: Nor-Epinephrine injection versus saline during PCNL

Interventions

Nor-Epinephrine injection versus saline during PCNLPROCEDURE

The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.

Nor-Epinephrine (NE)-GroupS-Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • renal stones\>2 cm

You may not qualify if:

  • coagulopathy, congenital anomalies, active Urinary tract infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Banha University Hospitals

Banhā, Kalubiaya, 13518, Egypt

Location

Banha university hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Officials

  • Waleed El-Shaer

    Faculty of medicine, Banha university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
double- blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 5, 2021

Study Start

March 10, 2020

Primary Completion

November 10, 2021

Study Completion

January 1, 2022

Last Updated

January 5, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)