UMIN-CTR Clinical Trial

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
Email	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
Email	me.nakamura@med.id.yamagata-u.ac.jp

Sponsor
Institute	Yamagata University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053344