|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT04081012 |
|
Date of registration:
|
16/08/2019 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension.
NAC-PostRep |
|
Scientific title:
|
N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Pulmonary Balloon Angioplasty and Pulmonary Endarterectomy. |
|
Date of first enrolment:
|
May 21, 2019 |
|
Target sample size:
|
34 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT04081012 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Mexico
| | | | | | | |
|
Contacts
|
|
Name:
|
Maria Elena Soto Lopez, Dr. |
|
Address:
|
|
|
Telephone:
|
5538808997 |
|
Email:
|
mesoto50@hotmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Huitzilihuitl Saucedo Orozco, Dr. |
|
Address:
|
|
|
Telephone:
|
4921373556 |
|
Email:
|
huitzilihuitls@hotmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Maria Elena Soto Lopez |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Instituto Nacional de CardiologĂa "Ignacio Chávez" |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients who are diagnosed with group 4 pulmonary hypertension and are susceptible to
pulmonary endarterectomy or balloon angioplasty in patients over 18 years.
Exclusion Criteria:
- Patients who do not accept admission to the trial.
- Presence of arterial hypotension or sepsis.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Thromboembolic Pulmonary Hypertension
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: N-acetyl cysteine
|
|
Primary Outcome(s)
|
|
Presence of Post-reperfusion pulmonary injury.
[Time Frame: 72 hours]
|
|
Secondary Outcome(s)
|
|
Concentration of cytokines (pg/ml)
[Time Frame: Basal and at 72 hours]
|
|
Percentaje of Complications (%)
[Time Frame: 30 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|