UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046758 |
|---|---|
| Receipt number | R000053344 |
| Scientific Title | Goal directed perfusion (GDP) using oxygen delivery index (DO2i) during cardiopulmonary resuscitation and incidence of postoperative acute kidney injury (AKI) |
| Date of disclosure of the study information | 2022/01/28 |
| Last modified on | 2022/01/28 11:07:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Goal directed perfusion (GDP) using oxygen delivery index (DO2i) during cardiopulmonary resuscitation and incidence of postoperative acute kidney injury (AKI)
Acronym
Goal directed perfusion (GDP) using oxygen delivery index (DO2i) during cardiopulmonary resuscitation and incidence of postoperative acute kidney injury (AKI)
Scientific Title
Goal directed perfusion (GDP) using oxygen delivery index (DO2i) during cardiopulmonary resuscitation and incidence of postoperative acute kidney injury (AKI)
Scientific Title:Acronym
Goal directed perfusion (GDP) using oxygen delivery index (DO2i) during cardiopulmonary resuscitation and incidence of postoperative acute kidney injury (AKI)
Region
| Japan |
Condition
Condition
Adult patients undergoing open heart surgery with artificial heart lung
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that controlling DO2i to 300 mL/min/m2 or higher would reduce the incidence of postoperative AKI, and that reducing the incidence of AKI would reduce intubation time and ICU stay, which would be beneficial in terms of patient outcome and medical economy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of AKI when DO2i is controlled at 300 mL/min/m2 or higher
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing open heart surgery with artificial heart lung at our hospital
Key exclusion criteria
Dialysis patients, patients with significant preoperative renal dysfunction (eGFR < 45mL/min/1.73m2), patients with circulatory arrest, patients with recurrent cardiac arrest, patients with difficulty in weaning from artificial heart lung, and patients who did not consent to participate in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kaneyuki |
| Middle name | |
| Last name | kawamae |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2, Iida-Nishi, Yamagata City
TEL
0236331122
me.nakamura@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | nakamura |
Organization
Yamagata University Medical School Hospital
Division name
Department of Clinical Engineering
Zip code
9909585
Address
2-2-2, Iida-Nishi, Yamagata City
TEL
0236285711
Homepage URL
me.nakamura@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Yamagata University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University Faculty of Medicine Ethics Committee
Address
2-2-2, Iida-Nishi, Yamagata City
Tel
0236331122
me.nakamura@med.id.yamagata-u.ac.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
| 2022 | Year | 01 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
If the DO2i falls below the target value, the perfusion rate or hematocrit level should be increased. The patient should be weaned from CPB and managed as usual thereafter. As a marker of inflammation, IL-6 will be measured after induction of anesthesia, after administration of protamine, upon admission to the ICU, and on the morning of the next day after surgery. As a marker of tubular damage, neutrophil gelatinase-binding lipokine will be measured after insertion of urinary catheter, at the end of cardiopulmonary resuscitation, in the ICU, and in the morning of the next day after surgery.
For IL-6, centrifuge the plasma after blood collection and store it frozen; for NGAL, centrifuge the supernatant after urine collection and store it refrigerated; for LSI, subcontract the stored specimens.
Collect the information from 1 to 3 from the medical record. 1.
1) Preoperative information
Gender, age, height, weight, body surface area, hematocrit level, eGFR, serum creatinine level, left ventricular ejection fraction, Euro score II
2. surgical information
surgical technique, operative time, cardiopulmonary time, aortic interruption time, minimum body temperature, minimum hematocrit level, blood transfusion volume during cardiopulmonary intervention, cardioprotective fluid infusion volume, urine volume during cardiopulmonary intervention, water removal volume, maximum lactate level, perfusion volume, perfusion pressure, DO2i, tissue oxygen saturation
3. postoperative information
Urine volume, serum creatinine level, intubation time, ICU stay, presence of renal replacement therapy
Management information
Registered date
| 2022 | Year | 01 | Month | 28 | Day |
Last modified on
| 2022 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053344
