Tense AscitesNCT02996188

Acute Hemodynamic Changes During Paracentesis

An observational study of Tense Ascites and Liver Cirrhosis, run by Universitätsmedizin Mannheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense ascites using non-invasive inert gas rebreathing. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Tense Ascites, Liver Cirrhosis
What is being tested?: routine therapeutic paracentesis
Type of treatment: Surgery or procedure
How many people: 36 participants
Where: No sites listed yet
Study dates: Jun 2012to Nov 2013
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing routine therapeutic paracentesis due to refractory tense ascites at a university hospital.

Who may be able to join

refractory tense ascites with indication for therapeutic paracentesis

Who cannot join

pregnancy
inability to give inform consent
inability to perform rebreathing maneuver

About this study

The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense ascites using non-invasive inert gas rebreathing.

Conditions: Tense Ascites, Liver Cirrhosis
Being tested: routine therapeutic paracentesis
Medical subject headings: Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

routine therapeutic paracentesisProcedure or surgery

Study groups in NCT02996188
Study group	Role	What they receive
Patients with refractory tense ascites		Not described Receives: Procedure: routine therapeutic paracentesis

What is being measured

The primary outcome is the main question the study is designed to answer.

change in cardiac output
prior to and after paracentesis
Measured: 30 minutes
change in systemic vascular resistance
prior to and after paracentesis
Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Nov 2013

First posted19 Dec 2016 (estimated)
Study startJun 2012
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tense AscitesStudies 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: Prospective
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02996188
Sponsor's protocol ID: IGR-paracentesis
Status last verified: Dec 2016
First submitted: 14 Dec 2016
Last updated: 19 Dec 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Hemodynamic Changes During Paracentesis
ClinicalTrials.gov ID: NCT02996188
Acronym / sponsor ID: IGR-paracentesis
Conditions: Tense Ascites, Liver Cirrhosis
Study type: Observational
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Universitätsmedizin MannheimUniversity, hospital or other
Study start: Jun 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 19 Dec 2016 (estimated)
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.

The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense ascites using non-invasive inert gas rebreathing.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with refractory tense ascites	–	Procedure: routine therapeutic paracentesis

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing routine therapeutic paracentesis due to refractory tense ascites at a university hospital.

Key inclusion criteria (1 listed)

refractory tense ascites with indication for therapeutic paracentesis

Key exclusion criteria (3 listed)

pregnancy
inability to give inform consent
inability to perform rebreathing maneuver

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
routine therapeutic paracentesis	Procedure or surgery	Patients with refractory tense ascites

Primary outcome

change in cardiac output
Time frame: 30 minutes
prior to and after paracentesis
change in systemic vascular resistance
Time frame: 30 minutes
prior to and after paracentesis

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Tense Ascites and Liver Cirrhosis, run by Universitätsmedizin Mannheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in cardiac output (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02996188.

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 19 Dec 2016.