UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058074 |
|---|---|
| Receipt number | R000066329 |
| Scientific Title | The Effect of Conventional Versus Pleth Variability Index-Guided Goal-Directed Intraoperative Fluid Management on Renal Function in Patients Undergoing Elective Total Abdominal Hysterectomy |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/03 04:33:15 |
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Basic information
Public title
Fluid Management and Kidney Function in Abdominal Hysterectomy: A Comparison Study
Acronym
HYDRIA
Scientific Title
The Effect of Conventional Versus Pleth Variability Index-Guided Goal-Directed Intraoperative Fluid Management on Renal Function in Patients Undergoing Elective Total Abdominal Hysterectomy
Scientific Title:Acronym
REN-HYS
Region
| Europe |
Condition
Condition
Renal outcomes related to intraoperative fluid therapy in abdominal hysterectomy
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate and compare the effects of conventional fluid therapy and Pleth Variability Index (PVI)-guided goal-directed fluid therapy on renal function in patients undergoing elective total abdominal hysterectomy. The study aims to determine whether individualized fluid management based on dynamic parameters such as PVI provides better renal protection compared to traditional static fluid management strategies during intraoperative care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was defined as the measurements of urea, creatinine, eGFR, and urine density in the preoperative, postoperative period, and on the third postoperative day. No secondary outcome was specified.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients aged between 18 and 65 years, classified as ASA physical status I and II, who underwent elective total abdominal hysterectomy under general anesthesia were included in the study.
Key exclusion criteria
Patients were excluded from the study if they met any of the following conditions: ASA score III and more, known renal failure, diabetes mellitus, use of diuretics, ischemic heart disease, congestive heart failure, cardiac arrhythmias, severe peripheral arterial disease, estimated blood loss greater than 20 percent of total volume, received blood transfusion, required more than 500 ml of colloid solution, needed vasopressor support, psychiatric conditions that impair ability to give informed consent
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | OGUZ |
| Middle name | KAGAN |
| Last name | AKSU |
Organization
University of Health Sciences Istanbul Training and Research Hospital
Division name
Anesthesiology and Reanimation
Zip code
34098
Address
Kasap Ilyas Mah. Org Nafiz Gurman Cd. Istanbul Egitim ve Arastirma Hastanesi 1. kat yogun bakim doktor odasi
TEL
902124596390
oguz.aksu94@gmail.com
Public contact
Name of contact person
| 1st name | IREMGUL |
| Middle name | |
| Last name | NALBAT |
Organization
University of Health Sciences Istanbul Training and Research Hospital
Division name
Anesthesiology and Reanimation
Zip code
34098
Address
Kasap Ilyas Mah. Org Nafiz Gurman Cd. Istanbul Egitim ve Arastirma Hastanesi 1. kat yogun bakim
TEL
902124596390
Homepage URL
iremnalbatt@gmail.com
Sponsor or person
Institute
University of Health Sciences Istanbul Training and Research Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Health Sciences Istanbul Training and Research Hospital
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 Health Sciences Istanbul Tranining and Research Ethics Committee
Address
Kasap Ilyas Mah. Org Nafiz Gurman Cd. Istanbul Egitim ve Arastirma Hastanesi
Tel
902124596225
ieahetikkurul@gmail.com
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
| 2025 | Year | 07 | Month | 01 | 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
68
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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study comparing renal function outcomes in patients undergoing elective total abdominal hysterectomy. Patients were assigned to fluid management strategies using sealed envelope randomization, but no interventional procedures were performed beyond standard clinical practice. Data were collected preoperatively, postoperatively, and on postoperative day 3.
Management information
Registered date
| 2025 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066329
