Prophylaxis Versus Treatment for TURP Syndrome. | NCT03428451

Studies
Prophylaxis Versus Treatment for TURP Syndrome.

NCT03428451

Sponsor

Ahmed Mohamed ELbadawy

Status

Unknown status

Last Update Posted

Dec 26, 2018Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Transurethral Resection of Prostate Syndrome

Interventions

NaCl 3% HS
NaCl 3% HS
NaCl 0.9% NS

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

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2018Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jan 26, 2018

First Submission Date that Met QC Criteria

Feb 4, 2018

First Posted Date

Feb 9, 2018Actual

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

Dec 23, 2018

Last Update Posted Date

Dec 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Mohamed ELbadawy, Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University, Kasr El Aini HospitalSponsor-Investigator

Lead Sponsor

Ahmed Mohamed ELbadawyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

The study will be conducted on 60 patients ASA class I - III BPH patients, candidates for TURP surgery using monopolar electronic resectoscope. Eligible patients will be allocated into one of three study groups (n=20 in each). Group A patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr; Group B patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr; while Group C patients will receive NaCl 0.9% Normal Saline(NS) at a dose of 6 ml/kg/hr. All intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. Vital signs [mean BP, HR, CVP & oxygen saturation (spO2)] will be recorded. Plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mOsm) will be measured. Incidence of TUR syndrome, need for ICU admission, post-operative ventilation and total hospital stay will be noted.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NaCl 3% HS	Drug	Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.	Group A (Hypertonic saline )

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum sodium level measured in mEq/L	Hyponatremia was defined as a serum sodium < 130 mEq/L	72 hours

Secondary Outcomes

Measure	Description	Time Frame
Incidence of TURP syndrome	Occurring TURP syndrome manifestations	72 hours
Need for ICU admission	For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA class I - III BPH patients

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Adult male BPH patients

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed ELbadawy, MD	Faculty of medicine- Cairo University- Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007010	Hyponatremia

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012462	Saline Solution, Hypertonic
D000077330	Saline Solution

Ancestor Terms

ID	Term
D006982	Hypertonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D000077324	Crystalloid Solutions

Browse Leaves

Not provided

Browse Branches

Not provided