Hypernatremia in Hydatid Cyst Treatment | NCT05090020

Studies
Hypernatremia in Hydatid Cyst Treatment

NCT05090020

Sponsor

Trabzon Kanuni Education and Research Hospital

Status

Unknown status

Last Update Posted

Oct 22, 2021Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Echinococcosis, Hepatic

Interventions

Treatment

Countries

Turkey (Türkiye)

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Oct 15, 2021Estimated

Completion Date

Oct 31, 2021Estimated

First Submitted Date

Sep 26, 2021

First Submission Date that Met QC Criteria

Oct 10, 2021

First Posted Date

Oct 22, 2021Actual

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

Oct 10, 2021

Last Update Posted Date

Oct 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aydın Aktaş, Associate Professor Doctor, Trabzon Kanuni Education and Research HospitalPrincipal Investigator

Lead Sponsor

Trabzon Kanuni Education and Research HospitalOTHER

Collaborators

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypertonic saline (HS) is one of the most widely used scolocidal agents in the treatment of hydatid cysts. Hypernatremia is one of the complications associated with the use of HS. It can cause hypernatremia, acid-base disorder, impaired lung, renal, cardiac and neurological functions and even death. Therefore, caution should be exercised in the use of HS, and open technique should be preferred in surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypernatremia		Hypernatremia (plasma sodium value above 145 mmol/L) due to HS use in the treatment of hydatid cyst.	Procedure: Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment	Procedure	Surgery and PAIR	Hypernatremia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevention of hypernatreima	Hypernatremia is plasma sodium value above 145 mmol/L.	3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Patients who developed hypernatremia (plasma sodium value above 145 mmol/L) due to HS use in the treatment of hydatid cyst were included to study -

Exclusion Criteria:Patients who developed hypernatremia due to other treatments were excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients treated who hydatid cyst with hypertonic saline

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aydıin Aktas	Contact	+905308807983		aydinaktas2004@gmail.com
Cuneyt Kayaalp	Contact			cuneytkayaalp@hotmail.com

Overall Officials

Name	Affiliation	Role
Aydin Aktas	Kanuni Training and Research Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aydıin Aktas	Recruiting	Trabzon	Ortahisar		Turkey (Türkiye)

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

Condition Browse Module

MeSH Terms

ID	Term
D004444	Echinococcosis, Hepatic
D004443	Echinococcosis
D006955	Hypernatremia

Ancestor Terms

ID	Term
D002590	Cestode Infections
D006373	Helminthiasis
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided