NCT03428451

Brief Summary

This study is designed to investigate the usage \& effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 10, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

January 26, 2018

Last Update Submit

December 23, 2018

Conditions

Transurethral Resection of Prostate Syndrome

Keywords

TURPhypertonic salineTURP syndromehyponatraemia

Outcome Measures

Primary Outcomes (1)

  • Serum sodium level measured in mEq/L

    Hyponatremia was defined as a serum sodium \< 130 mEq/L

    72 hours

Secondary Outcomes (2)

  • Incidence of TURP syndrome

    72 hours

  • Need for ICU admission

    72 hours

Study Arms (3)

Group A (Hypertonic saline )

ACTIVE COMPARATOR

patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr.

Drug: NaCl 3% HS

Group B (Hypertonic saline)

ACTIVE COMPARATOR

patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr.

Drug: NaCl 3% HS

Group C (Normal saline)

ACTIVE COMPARATOR

patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr.

Drug: NaCl 0.9% NS

Interventions

NaCl 3% HSDRUG

Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.

Also known as: Hypertonic saline
Group A (Hypertonic saline )
NaCl 0.9% NSDRUG

Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.

Also known as: Normal saline
Group C (Normal saline)

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAdult male BPH patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I - III BPH patients

You may not qualify if:

  • Patients having any condition contra-indicating regional anesthesia e.g impaired coagulation.
  • Electrolyte imbalance,
  • Uncontrolled hypertension,
  • Congestive heart failure or being allergic to local anesthetics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Hyponatremia

Interventions

Saline Solution, HypertonicSaline Solution

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsCrystalloid SolutionsIsotonic Solutions

Study Officials

  • Ahmed ELbadawy, MD

    Faculty of medicine- Cairo University- Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 9, 2018

Study Start

February 10, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 26, 2018

Record last verified: 2018-12

Locations

EG(1)