UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037052 |
|---|---|
| Receipt number | R000042178 |
| Scientific Title | verify the effect of blood purification in septic shock |
| Date of disclosure of the study information | 2019/06/16 |
| Last modified on | 2023/06/11 20:52:50 |
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Basic information
Public title
verify the effect of blood purification in septic shock
Acronym
blood purification in septic shock
Scientific Title
verify the effect of blood purification in septic shock
Scientific Title:Acronym
blood purification in septic shock
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify the effect of blood purification therapy for septic shock. For septic shock, supportive care with surgical drainage and catecholamine is the common treatment. However there often happens complications of acute kidney injury, such as hyperkalemia or metabolic acidosis and blood purification therapy (RRT: renal replacement therapy) is often required. We have experienced many cases that showed improvement in general condition after RRT introduction, but when and how to initiate RRT is not clarified yet. A treatment protocol was developed for septic shock after gastrointestinal surgery. In order to remove inflammatory cytokines and anti-inflammatory cytokines, it was decided to use HDF (hemodiafiltration). We will evaluate whether the prognosis will be better compared to the predicted mortality rate by APACHE (acute physiology and chronic health evaluation) II score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
90-day mortality
Key secondary outcomes
28-day mortality, 180-day mortality, SOFA score
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. postoperative abdominal surgery
2. Patients with septic shock who require noradrenaline at least 0.1 mcg/kg/min
3. Patients diagnosed with AKI according to KDIGO diagnostic criteria
Key exclusion criteria
1. Patients with end-stage renal failure
2. Patients with obstructed urinary tract
3. Patients who have a history of emergency dialysis
4. Patients already undergoing renal replacement therapy
5. Patients for whom " do not attempt resuscitation " has been acquired
6. Patients judged to be inappropriate for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Yokoyama |
Organization
Ogaki Municipal Hospital
Division name
Anesthesiology
Zip code
503-8502
Address
4-86, Minaminokawa, Ogaki, Gifu, Japan
TEL
0584-81-3341
tyinnagoyauniversity@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Yokoyama |
Organization
Ogaki Municipal Hospital
Division name
Anesthesiology
Zip code
503-8502
Address
4-86, Minaminokawa, Ogaki, Gifu, Japan
TEL
0584-81-3341
Homepage URL
tyinnagoyauniversity@gmail.com
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ogaki Municipal Hospital
Address
4-86, Minaminokawa, Ogaki, Gifu, Japan
Tel
0584-81-3341
clinical-trial@omh.ogaki.gifu.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood purification therapy is performed with high volume HDF (Qb 150 mL/min, Qd 300 mL/min, Qf 1000 mL/h, dewatering 0 mL/h) for 10 hours, and then CHDF with AN69ST membrane ( Qb 100 mL / min, Qd 300 mL / min, Qf 600 mL / h).
Management information
Registered date
| 2019 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042178
