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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| National Natural Science Foundation of China | OTHER_GOV |
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HeSAPP is a single-center, non-blinded, parallel-group randomized controlled trial studying the hemopurification strategy for acute paraquat(PQ) 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis (HD) | Experimental | Patients in this group would receive hemodialysis for 3 days consecutively besides conservative therapy. |
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| Hemoperfusion (HP) | Experimental | Patients in this group would receive hemoperfusion for 3 days consecutively besides conservative therapy. |
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| HP-HD | Experimental | Patients in this group would receive hemoperfusion and hemodialysis concurrent therapy for 3 days consecutively besides conservative therapy. |
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| Conservative | No Intervention | Patients in this group would receive basic supportive treatment, gastric lavage, glucosteroid and immunosuppressive drugs without any hemopurification. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodialysis | Procedure | Participants in this group will be catheterize in the internal jugular vein and connect to a hemodialysis machine. |
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| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality | Mortality=Dead patients/All patients in that group | From the day of intoxication to the 28th day afterwards. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival time | Live day count. | From the day of intoxication to death or the 60th day. |
| Rate of multiple organ failure | Patients that develop multiple organ failure/All patients in that group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Li, M.D. | Contact | +86-13693109826 | billliyi@126.com | |
| Shiyuan Yu, M.D. | Contact | +86-18904015983 | 362384870@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Li, M.D. | Peking Union Medical College Hospital | Study Chair |
| Yanxia Gao | The First Affiliated Hospital of Zhengzhou University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29934393 | Derived | Cui JW, Xu Y, Wang Y, Gao YX, Guo S, Wang M, Lu X, Yu S, Ma Y, Yuan D, Che L, Sun P, Yu X, Zhu H, Li Y. Efficacy of initial haemopurification strategy for acute paraquat poisoning in adults: study protocol for a randomised controlled trial (HeSAPP). BMJ Open. 2018 Jun 22;8(6):e021964. doi: 10.1136/bmjopen-2018-021964. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2018 | Apr 12, 2018 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2018 | Apr 12, 2018 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D011041 | Poisoning |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| D006464 | Hemoperfusion |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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Parallel Assignment
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This study is designed as a non-blinded trial because of the apparently different equipment of the interventions
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| Hemoperfusion | Procedure | Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine. |
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| HP-HD | Procedure | Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine and then a hemodialysis machine for one course. |
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| From the day of intoxication to death or the 60th day. |
| Rate of oxygen uptake | Patients that need oxygen therapy/All patients in that group | From the day of intoxication to death or the 60th day. |
| Rate of mechanical ventilation | Patients that need mechanical ventilation/All patients in that group | From the day of intoxication to death or the 60th day. |
| In-hospital length of stay | Day count from admission to discharge or the end of follow up. | From the day of admission to discharge or up to 60 days after admission. |
| 3-day all-cause mortality | Mortality=Dead patients/All patients in that group | From the day of intoxication to the 3rd day afterwards. |
| 7-day all-cause mortality | Mortality=Dead patients/All patients in that group | From the day of intoxication to the 7th day afterwards. |
| 60-day all-cause mortality | Mortality=Dead patients/All patients in that group | From the day of intoxication to the 60th day afterwards. |
| ICU length of stay | Day count spent in intensive care unit | From the day of intoxication to death or the 60th day. |
| Rate of catheter related complications | Complications due to catheterization, e.g. thrombocytopenia, deep venous thrombosis, catheter related infection. | From the day of intoxication to death or the 60th day. |
| D013514 | Surgical Procedures, Operative |