N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension.

NCT04081012 | Unknown DMC

• 1 other identifier: 191110
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the use of N-acetyl cysteine in post-reperfusion pulmonary injury in patients with chronic thromboembolic pulmonary hypertension undergoing pulmonary balloon angioplasty and pulmonary endarterectomy. Half of the patients will receive N-acetyl cysteine and the other placebo.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Presence of Post-reperfusion pulmonary injury.

  Chest tomography will be performed using 35 mA, 100 Kv and 6 mm cuts, then the simple thorax (low dose) holding the inspiration in the cephalocaudal direction with 80 mA, 100 Kv, a duration of 2.24 seconds, pitch of 1 and cuts 1 mm Multiplanar reconstructions with Kernel filters B26f, B50f and B70f for mediastinum and lung respectively, at 1 mm cuts. And anteroposterior chest radiographs will be obtained with the same equipment, at the beginning of the study and daily on days 1 to 3.

  72 hours

Secondary Outcomes (2)

• Concentration of cytokines (pg/ml)

  Basal and at 72 hours

• Percentaje of Complications (%)

  30 days

Study Arms (2)

N-acetyl Cysteine

EXPERIMENTAL

Patients will receive a 4-dose schedule of 600 mg diluted in 50 ml of 0.9% saline intravenously every 12 hours starting 24 hours before endarterectomy or balloon angioplasty.

Drug: N-acetyl cysteine

Placebo

PLACEBO COMPARATOR

The placebo group will receive a similar volume of normal saline as a placebo at the same time intervals. All study medications will be prepared by the Pharmacology department, which is not involved in patient care; the name of the medication and dose of the original ampule will be erased and also an identification label will be placed with the name, registration number, bed number, date and will be indifferent for groups with the same type of ampoule, with the same type of labeling

Drug: Placebo

Interventions

N-acetyl cysteine DRUG

Patients will receive a 4-dose schedule of 600 mg diluted in 50 ml of 0.9% saline intravenously every 12 hours starting 24 hours before pulmonary endarterectomy or balloon pulmonary angioplasty.

Also known as: NAC

N-acetyl Cysteine

Placebo DRUG

The placebo group will receive a similar volume of normal saline as a placebo at the same time intervals.

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients who are diagnosed with group 4 pulmonary hypertension and are susceptible to pulmonary endarterectomy or balloon angioplasty in patients over 18 years.

You may not qualify if:

• Patients who do not accept admission to the trial.
• Presence of arterial hypotension or sepsis.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional Ignacio Chavez

Mexico City, 14080, Mexico

RECRUITING

Related Publications (9)

• Konstantinides SV, Barco S, Lankeit M, Meyer G. Management of Pulmonary Embolism: An Update. J Am Coll Cardiol. 2016 Mar 1;67(8):976-990. doi: 10.1016/j.jacc.2015.11.061.

  PMID: 26916489 BACKGROUND

• Huisman MV, Barco S, Cannegieter SC, Le Gal G, Konstantinides SV, Reitsma PH, Rodger M, Vonk Noordegraaf A, Klok FA. Pulmonary embolism. Nat Rev Dis Primers. 2018 May 17;4:18028. doi: 10.1038/nrdp.2018.28.

  PMID: 29770793 BACKGROUND

• Pengo V, Lensing AW, Prins MH, Marchiori A, Davidson BL, Tiozzo F, Albanese P, Biasiolo A, Pegoraro C, Iliceto S, Prandoni P; Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004 May 27;350(22):2257-64. doi: 10.1056/NEJMoa032274.

  PMID: 15163775 BACKGROUND

• Ogawa A, Satoh T, Fukuda T, Sugimura K, Fukumoto Y, Emoto N, Yamada N, Yao A, Ando M, Ogino H, Tanabe N, Tsujino I, Hanaoka M, Minatoya K, Ito H, Matsubara H. Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Results of a Multicenter Registry. Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e004029. doi: 10.1161/CIRCOUTCOMES.117.004029.

  PMID: 29101270 BACKGROUND

• Wilkens H, Lang I, Behr J, Berghaus T, Grohe C, Guth S, Hoeper MM, Kramm T, Kruger U, Langer F, Rosenkranz S, Schafers HJ, Schmidt M, Seyfarth HJ, Wahlers T, Worth H, Mayer E. Chronic thromboembolic pulmonary hypertension (CTEPH): updated Recommendations of the Cologne Consensus Conference 2011. Int J Cardiol. 2011 Dec;154 Suppl 1:S54-60. doi: 10.1016/S0167-5273(11)70493-4.

  PMID: 22221974 BACKGROUND

• Laubach VE, Sharma AK. Mechanisms of lung ischemia-reperfusion injury. Curr Opin Organ Transplant. 2016 Jun;21(3):246-52. doi: 10.1097/MOT.0000000000000304.

  PMID: 26945320 BACKGROUND

• Zabini D, Heinemann A, Foris V, Nagaraj C, Nierlich P, Balint Z, Kwapiszewska G, Lang IM, Klepetko W, Olschewski H, Olschewski A. Comprehensive analysis of inflammatory markers in chronic thromboembolic pulmonary hypertension patients. Eur Respir J. 2014 Oct;44(4):951-62. doi: 10.1183/09031936.00145013. Epub 2014 Jul 17.

  PMID: 25034560 BACKGROUND

• Sun Y, Pu LY, Lu L, Wang XH, Zhang F, Rao JH. N-acetylcysteine attenuates reactive-oxygen-species-mediated endoplasmic reticulum stress during liver ischemia-reperfusion injury. World J Gastroenterol. 2014 Nov 7;20(41):15289-98. doi: 10.3748/wjg.v20.i41.15289.

  PMID: 25386077 BACKGROUND

• Geudens N, Wuyts WA, Rega FR, Vanaudenaerde BM, Neyrinck AP, Verleden GM, Lerut TE, Van Raemdonck DE. N-acetyl cysteine attenuates the inflammatory response in warm ischemic pig lungs. J Surg Res. 2008 May 15;146(2):177-83. doi: 10.1016/j.jss.2007.05.018. Epub 2007 Jul 20.

  PMID: 17644109 BACKGROUND

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Maria Elena Soto Lopez

  Instituto Nacional de Cardiología "Ignacio Chávez"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Elena Soto Lopez, Dr.

CONTACT

5538808997; mesoto50@hotmail.com

Huitzilihuitl Saucedo Orozco, Dr.

CONTACT

4921373556; huitzilihuitls@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: It will be through sealed, opaque and numbered envelopes sequentially. The assignment sequence will be done by the pharmacist, the principal investigator will recruit the patients. Researchers and site staff (with the exception of the investigating pharmacologist) will be blinded to the assigned treatment. There will be no circumstances to unmask and reveal the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research

Model Details: Randomized, double-blind clinical trial of the treatment will be the treating physician and radiologist, of parallel groups in patients undergoing EAP and BPA.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: September 6, 2019
• Study Start: May 21, 2019
• Primary Completion: May 21, 2023
• Study Completion: May 21, 2023
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 8 months of study completion.
• Access Criteria: Data access request will be reviewed by an internal review panel. Requestors will be required to sign a Data Access Agreement.

Locations

ME (1)