Echinococcosis, HepaticNCT05090020
Hypernatremia in Hydatid Cyst Treatment
An observational study of Echinococcosis, Hepatic, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 90 years
- Conditions the study is for
- Echinococcosis, Hepatic
- What is being tested?
- Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated who hydatid cyst with hypertonic saline
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.
-
Trial locations and contacts
1 site in 1 country.
Cuneyt Kayaalp contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydıin Aktas
Trabzon, Ortahisar
Aydıin Aktas, 05308807983, aydinaktas2004@gmail.com
About this study
Official title: Systematic Review of Hypernatremia Following Hydatid Cyst Treatment
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.
- Conditions
- Echinococcosis, Hepatic
- Being tested
- Treatment
- Keywords
- Echinococcosis, Hepatic, hypernatremia
- Medical subject headings
- Echinococcosis, Hepatic, Echinococcosis, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentProcedure or surgery
Surgery and PAIR
| Study group | Role | What they receive |
|---|---|---|
| Hypernatremia | Hypernatremia (plasma sodium value above 145 mmol/L) due to HS use in the treatment of hydatid cyst. Receives: Procedure: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of hypernatreima
Hypernatremia is plasma sodium value above 145 mmol/L.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Feb 2021
- Primary completion15 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Echinococcosis, HepaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydın Aktaş, Trabzon Kanuni Education and Research Hospital
- Investigators
- Aydin Aktas, Study chair, Kanuni Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090020
- Sponsor's protocol ID
- TrabzonKERH
- Status last verified
- Oct 2021
- First submitted
- 26 Sep 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Review of Hypernatremia Following Hydatid Cyst Treatment
- ClinicalTrials.gov ID
- NCT05090020
- Acronym / sponsor ID
- TrabzonKERH
- Conditions
- Echinococcosis, Hepatic
- Keywords
- Echinococcosis, Hepatic, hypernatremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypernatremia | – | Procedure: TreatmentHypernatremia (plasma sodium value above 145 mmol/L) due to HS use in the treatment of hydatid cyst. |
Who may qualify
- Ages
- 7 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated who hydatid cyst with hypertonic saline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentSurgery and PAIR | Procedure or surgery | Hypernatremia |
Primary outcome
Prevention of hypernatreima
Time frame: 3 month
Hypernatremia is plasma sodium value above 145 mmol/L.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cuneyt Kayaalp contact
Aydin Aktas study chair
Kanuni Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echinococcosis, Hepatic, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aydıin Aktas (+905308807983, aydinaktas2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of hypernatreima (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.