UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058061 |
|---|---|
| Receipt number | R000066364 |
| Scientific Title | Concordance between Internal Jugular Vein Variability Index and Plethysmographic Variability Index in Laparoscopic Nephrectomy: An Observational Study |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/26 23:59:31 |
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Basic information
Public title
Concordance between Internal Jugular Vein Variability Index and Plethysmographic Variability Index in Laparoscopic Nephrectomy: An Observational Study
Acronym
PIJV-VI Study
Scientific Title
Concordance between Internal Jugular Vein Variability Index and Plethysmographic Variability Index in Laparoscopic Nephrectomy: An Observational Study
Scientific Title:Acronym
PIJV-VI Study
Region
| North America |
Condition
Condition
Living renal donor aged between 18 and 70 years, scheduled for elective surgery, undergoing hemodynamic monitoring that includes Internal Jugular Vein Variability Index (IJV-VI) and Plethysmographic Variability Index (PVI)
Classification by specialty
| Nephrology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.- To assess the concordance between Internal Jugular Vein Variability Index and Plethysmographic Variability Index in living renal transplant donors.
Basic objectives2
Others
Basic objectives -Others
1.- To assess the Internal Jugular Vein Variability Index (IJV-VI) in living renal transplant donors during the intraoperative period.
2.- To assess the Plethysmographic Variability Index (PVI) in living renal transplant donors during the intraoperative period.
3.- To assess whether the side of nephrectomy (left or right) influences the values or concordance between the Internal Jugular Vein Variability Index and Plethysmographic Variability Index.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the agreement between the Internal Jugular Vein Variability Index (IJV-VI) and the Plethysmographic Variability Index (PVI) during the intraoperative period in living renal transplant donors
Key secondary outcomes
To determine the agreement between the Internal Jugular Vein Variability Index (IJV-VI) and the Plethysmographic Variability Index (PVI) during the intraoperative period according to the side of the nephrectomy (left vs. right)
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.- Patients who signed informed consent and agreed to participate in the study.
2.- Living kidney donors aged >18 and <70 years.
3.- Undergoing complete hemodynamic monitoring including Internal Jugular Vein Variability Index (IJV-VI) and Plethysmographic Variability Index (PVI)
4.- Patients classified as ASA Physical Status I or II.
Key exclusion criteria
1.- Patients requiring conversion from laparoscopic to open surgical technique.
2.- Patients who develop intraoperative complications such as significant hemorrhage.
3.- Patients with a medical history of Raynaud's disease.
4.- Patients requiring high-dose norepinephrine infusion (>0.1 mcg/kg/min) during the intraoperative period.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Sebastian |
| Middle name | |
| Last name | Sanchez Brito |
Organization
Instituto Mexicano del Seguro Social
Division name
Anesthesiology Department
Zip code
02990
Address
Paseo de las Jacarandas Sin Numero, Colonia La Raza, Azcapotzalco, Ciudad de Mexico
TEL
+522227930116
sanchez.brito.sebastian@gmail.com
Public contact
Name of contact person
| 1st name | Diego |
| Middle name | |
| Last name | Escarraman Martinez |
Organization
Instituto Mexicano del Seguro Social
Division name
Anesthesiology Department
Zip code
02990
Address
Paseo de las Jacarandas Sin Numero, Colonia La Raza, Azcapotzalco, Ciudad de Mexico
TEL
2227930116
Homepage URL
diego-piloto@gmail.com
Sponsor or person
Institute
Self-funding
Institute
Department
Personal name
Funding Source
Organization
Self-Funding
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
Ethical teaching and research Unidad Medica de Alta Especialidad "Dr. Antonio Fraga Mouret"
Address
Paseo de las Jacarandas Sin Numero, Colonia La Raza, Azcapotzalco, Ciudad de Mexico
Tel
57245900 ext.23075
diego-piloto@hotmail.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 | 10 | 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
36
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Total participants: 36 living kidney donors (from 39 estimated).
Exclusions: 3 patients with ASA greater or equal to III.
Median age: 46 years (IQR 36 55).
Sex: 23 female (63.9 percent), 13 male (36.1 percent).
BMI: median 26.2 kg per m2 (IQR 23.7 28.5).
Heart rate: median 62 bpm (IQR 55 68.8).
Mean arterial pressure: median 81 mmHg (IQR 72 89).
ASA class: ASA II in 33 (91.6 percent), ASA I in 3 (8.3 percent).
Position: right lateral decubitus in 24 cases (66.7 percent), left lateral decubitus in 12 cases (33.3 percent).
Participant flow
Assessed for eligibility: 39 donors.
Excluded: 3 patients with ASA greater or equal to III.
Enrolled: 36 donors.
Intraoperative measurements: 366 obtained.
Analyzed: all 36 participants included in statistical analysis.
Dropouts: none.
Adverse events
No adverse events directly related to the study are expected. The procedures are standard of care in donor nephrectomy under general anesthesia. The monitoring methods used (PVI and jugular ultrasound) are non-invasive or minimally invasive, and carry no additional risks to participants. Any perioperative complications will be managed as part of standard clinical care.
Outcome measures
Primary outcome: Agreement between Pleth Variability Index (PVI) and Internal Jugular Vein Variability Index (IJV VI) during donor nephrectomy, assessed with Bland Altman and polar plot analysis.
Plan to share IPD
No plan to share individual participant data due to ethical and privacy considerations. De-identified datasets may be made available upon reasonable request and subject to approval by the institutional ethics committee
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The agreement between IJV-VI and PVI will be assessed using both Bland-Alman analysis and polar plot methodology. Bland-Alman plots will evaluate the bias and limits of agreement between the two methods, considering repeated measures per subject. Additionally, a polar plot will be constructed to assess directional agreement, focusing on trending ability and angular concordance. This dual approach allows a robust assessment of both absolute agreement and trending reliability between the two indices during laparoscopic donor nephrectomy.
Management information
Registered date
| 2025 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066364
