UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061057 |
|---|---|
| Receipt number | R000069637 |
| Scientific Title | Anesthesia-related Risk Determinants of Post-Induction Hypotension in Emergency Surgery for Lower Gastrointestinal Perforation (GUARD-PIH study): A Multicenter Retrospective Observational Study |
| Date of disclosure of the study information | 2026/03/25 |
| Last modified on | 2026/03/27 22:17:09 |
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Basic information
Public title
Anesthesia-related Risk Determinants of Post-Induction Hypotension in Emergency Surgery for Lower Gastrointestinal Perforation (GUARD-PIH study): A Multicenter Retrospective Observational Study
Acronym
GUARD-PIH study (Gastrointestinal perforation in Urgent surgery: Anesthesia-related Risk Determinants of Post-Induction Hypotension)
Scientific Title
Anesthesia-related Risk Determinants of Post-Induction Hypotension in Emergency Surgery for Lower Gastrointestinal Perforation (GUARD-PIH study): A Multicenter Retrospective Observational Study
Scientific Title:Acronym
GUARD-PIH study (Gastrointestinal perforation in Urgent surgery: Anesthesia-related Risk Determinants of Post-Induction Hypotension)
Region
| Japan |
Condition
Condition
lower gastrointestinal perforation
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of anesthetic induction agents on the incidence of post-induction hypotension and peri-induction blood pressure changes, and to generate evidence to inform the optimal choice of induction agents in critically ill patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure during the 30 minutes following anesthetic induction
Key secondary outcomes
Heart rate during the first 30 minutes after anesthetic induction, Cardiac arrest within 30 minutes after anesthetic induction, Arterial blood gas values during anesthetic induction, Location of extubation, ICU admission, In-hospital mortality
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 who underwent emergency surgery for lower gastrointestinal perforation (ascending colon to rectum) between April 1, 2022, and October 31, 2025.
Key exclusion criteria
1) Pregnancy, 2) Refusal of data use via the opt-out process, 3) Use of mechanical circulatory support, 4) Patients already intubated upon operating room admission, 5) Presence of a permanent tracheostomy or tracheostomy, 6) Missing key variables, including anesthetic induction agents or blood pressure measurements at induction, 7) Postoperative diagnosis indicating that the perforation site was outside the lower gastrointestinal tract
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takazawa |
Organization
University of Toyama
Division name
Department of Anesthesiology
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
TEL
076-434-7377
takazawt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Yatabe |
Organization
Nishichita General Hospital
Division name
Emergency department
Zip code
477-8522
Address
3-1-1, Nakano-ike, Tokai, Aichi
TEL
0562-33-5500
Homepage URL
yatabe.tomoaki@katch.ne.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
University of Toyama
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
Tel
076-415-8857
kenrinri@adm.u-toyama.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
| 2026 | Year | 03 | Month | 25 | 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
| 2026 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Multicenter retrospective observational study
Data collection: Age, Gender, Height, Weight, American Society of Anesthesiologists (ASA) physical status classification, Comorbidities (chronic pulmonary disease, diabetes mellitus, malignancy, congestive heart failure/ischemic heart disease, valvular heart disease, hypertension, dialysis, and liver failure),
Method of anesthetic induction, Surgical procedure, Blood pressure and heart rate from before anesthetic induction to 30 minutes after induction, Anesthetic induction agents, Vasopressor use, Blood gas analysis results, Cardiac arrest within 30 minutes after induction, Extubation in the operating room, Postoperative ICU admission, Hospital outcomes
Statistical analysis: The median blood pressure and heart rate during the first 30 minutes after anesthetic induction will be calculated. Post-induction hypotension will be defined as a decrease in blood pressure of more than 20% from the pre-induction value. The incidence of post-induction hypotension will be determined, and logistic regression analysis will be performed to identify factors associated with post-induction hypotension.
Management information
Registered date
| 2026 | Year | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069637
