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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037052
Receipt No. 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 2019/06/13

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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
Email 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
Email tyinnagoyauniversity@gmail.com

Sponsor
Institute Ogaki Municipal Hospital
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042178

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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