Ignite Creation Date:
2024-05-06 @ 10:39 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03314909
Status:
UNKNOWN
Last Update Posted:
2018-04-17
First Post:
2017-10-10
Brief Title:
Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
The Efficacy of Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults Study Protocol for a Randomized Controlled Trial HeSAPP
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HeSAPP is a single-center non-blinded parallel-group randomized controlled trial studying the hemopurification strategy for acute paraquatPQ poisoned patients The intervention to be investigated include hemodialysis HD hemoperfusion HP combined hemoperfusion-hemodialysis concurrent therapy HP-HD and conservative therapy The object of the present trial is to investigate whether hemopurification therapy can reduce mortality compared with conservative therapy
Detailed Description:
Patients diagnosed with acute paraquat poisoning in the Emergency Room of the First Affiliated Hospital of Zhengzhou University would be stratified according to their urine dithionite test results and randomly assigned to four different groups HD HP HP-HD and control conservative therapy group for different treatment Arterial blood gas test complete blood count coagulation function liver function pancreatic function urine dithionite test renal function and chest radiographs would be closely monitored during treatment Primary endpoint is 28-day mortality Secondary endpoints include 1 survival time from the time of PQ ingestion to the time of death all-cause mortality at the 3rd 7th and 60th day 2 rate of necessary oxygen uptake and rate of mechanical ventilation 3 in-hospital length of stay and ICU length of stay 4 APACHE II score and PSS score 5 rate of general complications such as respiratory failure acute kidney injury AKI acute liver failure pancreas function abnormality and Multiple Organ Failure MOF 6 rate of intervention related complications such as catheter placement related complications thrombocytopenia and deep venous thrombosis 7 rate of adverse events which include unexpected death severe hemorrhage or edema unplanned extubation coagulation in the extracorporeal circulation blockage of cartridge incorrect pipe connection etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None