NCT05090020

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.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

September 26, 2021

Last Update Submit

October 10, 2021

Conditions

Echinococcosis, Hepatic

Keywords

EchinococcosisHepatichypernatremia

Outcome Measures

Primary Outcomes (1)

  • Prevention of hypernatreima

    Hypernatremia is plasma sodium value above 145 mmol/L.

    3 month

Study Arms (1)

Hypernatremia

Hypernatremia (plasma sodium value above 145 mmol/L) due to HS use in the treatment of hydatid cyst.

Procedure: Treatment

Interventions

TreatmentPROCEDURE

Surgery and PAIR

Hypernatremia

Eligibility Criteria

Age7 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated who hydatid cyst with hypertonic saline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydıin Aktas

Trabzon, Ortahisar, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Echinococcosis, HepaticEchinococcosisHypernatremia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cestode InfectionsHelminthiasisParasitic DiseasesInfectionsLiver Diseases, ParasiticLiver DiseasesDigestive System DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Aydin Aktas

    Kanuni Training and Research Hospital

    STUDY CHAIR

Central Study Contacts

Aydıin Aktas

CONTACT

+905308807983aydinaktas2004@gmail.com

Cuneyt Kayaalp

CONTACT

cuneytkayaalp@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 22, 2021

Study Start

February 1, 2021

Primary Completion

October 15, 2021

Study Completion

October 31, 2021

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)