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NCT04552028: SAFI
Respiratory Dysfunction in Acute Pancreatitis (SAFI)
trial testing Non invasive oxygenation in Acute Pancreatitis in 74 participants. Status unknown.
15 January 2021
Quick facts
| Lead sponsor | Dr. med. Hector Eloy Tamez Perez |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 74 |
| Start date | 15 December 2019 |
| Primary completion | 15 January 2021 |
| Estimated completion | 31 January 2021 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Non invasive oxygenation
Conditions studied
- Acute Pancreatitis — all drugs for Acute Pancreatitis →
- Complication — all drugs for Complication →
Sponsor
Dr. med. Hector Eloy Tamez Perez
Who can join
18 and older, any sex, with Acute Pancreatitis or Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Acute pancreatitis (AP) is an inflammatory process of the pancreas and is one of the main causes of hospital admission of gastrointestinal origin. The annual incidence is between 13 to 45 per 100,000 habitants. The etiology may correspond to vesicular gallstones, excessive alcohol consumption, drugs, among others. Risk factors such as smoking and type 2 diabetes mellitus have been found to increase the risk of pancreatitis by 1.86 to 2.89 times. Pulmonary complications are the most frequent in this group of patients, approximately in 75% of cases, they vary from hypoxemia to acute respiratory distress syndrome (ARDS). In the first 2 days of hospital admission, tachypnea, mild respiratory alkalosis and hypoxemia may occur, usually without radiological manifestations, however 33% of patients with AP have pulmonary complications with symtoms and radiological signs, some of them are atelectasis (15%), small pleural effusion (4-17%) mainly of right lung and pulmonary edema (8-50%). Non-invasive methods would allow faster identification of patients with hypoxemia or patients who have pulmonary organ failure. (6) There is no evidence on the usefulness of SpO2 / FiO2 (SF) as a predictor of hypoxemia and its correlation with PaO2 / FiO2 in acute pancreatitis, however its continuous calculation can greatly reduce arterial gas intake and decrease adverse events and costs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04552028
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04552028 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. med. Hector Eloy Tamez Perez
- Last refreshed: 17 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04552028.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing