UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014991 |
|---|---|
| Receipt number | R000017262 |
| Scientific Title | The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2023/03/25 10:05:25 |
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Basic information
Public title
The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients
Acronym
The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients
Scientific Title
The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients
Scientific Title:Acronym
The prospective observational study to assess the association of peri-operative managements with the incidence of postoperative complications in cardiac surgery patients
Region
| Japan |
Condition
Condition
cardiac surgery/Major vascular surgery
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
| Surgery in general | Vascular surgery | Anesthesiology |
| Cardiovascular surgery | Blood transfusion | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the association of blood glucose management and presence of hemolysis with incidence of postoperative complications in cardiovascular surgery with cardiopulmonary bypass.
Basic objectives2
Others
Basic objectives -Others
To observe the association of the peri-operative management with the incidence of postoperative complications including delirium and organ failures in cardiovascular surgery with cardiopulmonary bypass.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of acute kidney injury (RIFLE criteria)
Key secondary outcomes
The duration of postoperative hospital stay
The duration of postoperative ICU stay
The duration required postoperative mechanical ventilatory support
The presence of organ failures (SOFA score)
The presence of postoperative respiratory complications associated with mechanical ventilation (VAC criteria)
The incidence of postoperative delirium (CAM-ICU)
The strength of oxidative stress
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years old undergoing cardiovascular using cardiopulmonary bypass at Kobe University Hospital.
Those who obtained informed consent related with this study.
Key exclusion criteria
Patients with chronic renal dysfunction (serum creatinine is equal or more than 2mg/dL)
Patients who require hemodialysis.
patients with any conditions which cause hemolysis.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Moritoki |
| Middle name | |
| Last name | Egi |
Organization
Kobe University Hospital
Division name
Anesthesiology
Zip code
6500017
Address
7-5-2 Kusunokicho Chuoku, Kobe, Hyogo
TEL
0783826172
moriori@tg8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Kubota |
Organization
Kobe University Hospital
Division name
Anesthesiology
Zip code
6500017
Address
7-5-2 Kusunokicho Chuoku, Kobe, Hyogo
TEL
0783826172
Homepage URL
kentanyl@gmail.com
Sponsor or person
Institute
Kobe University Hospital, Anesthesiology Department
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB comittee Kobe University hospital
Address
7-5-2 kusunokityo Kobe city hyogo
Tel
078-382-5111
moriori@tg8.so-net.ne.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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1053/j.jvca.2021.04.029
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1053/j.jvca.2021.04.029
Number of participants that the trial has enrolled
120
Results
We obtained perioperative free hemoglobin(fHb) and haptoglobin(Hp) levels during the study period in adult patients undergoing valvular and aortic surgery requiring cardiopulmonary bypass (CPB). The increase of fHb level and decrease of Hp level had independent associations with post operative AKI. And, we estimated cutoff values were 0.06g/dL at CPB1(1hr after CPB) , 0.12g/dL as preoperative maximum fHb(maxfHb), respectively.
Results date posted
| 2023 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We evaluated 120 patients without chronic renal failure who underwent cardiac surgery that required CPB . Among them, we excluded patients who were administered external haptoglobin in the perioperative period and patients in whom more than one CPB or reoperation was performed. We finally included 74 patients in this study.Postoperative AKI occurred in 25 (33.8%) of those patients.Patients with AKI were significantly older than patients without AKI (p=0.01) and had a lower preoperative eGFR (p=0.04) than that in patients without AKI. The median value of MAP during CPB in patients with AKI was 51.3 (43.9-63.4) mmHg, which was not significantly different from the median value of 54.5 (45.3-64.8) mmHg in patients without AKI (p=0.49). There was no significant difference in other demographics.
Participant flow
We evaluated 120 patients without chronic renal failure who underwent cardiac surgery that required CPB . Among them, we excluded patients who were administered external haptoglobin in the perioperative period and patients in whom more than one CPB or reoperation was performed. We finally included 74 patients in this study.
Adverse events
Nothing of note
Outcome measures
The primary outcome was postoperative AKI defined by Kidney Disease: Improving Global Outcomes. Postoperative AKI was determined by an increase in creatinine level of 0.3 mg/dl or more above the preoperative value or an increase in creatinine level of 50% or more within 48hours after the operation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 08 | Month | 01 | Day |
Other
Other related information
?
Management information
Registered date
| 2014 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017262
