UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058829 |
|---|---|
| Receipt number | R000067264 |
| Scientific Title | Association between Acute Respiratory Acidosis and Hyperkalemia During Esophageal Cancer Surgery in the Prone Position: A Retrospective Observational Study |
| Date of disclosure of the study information | 2025/08/19 |
| Last modified on | 2025/08/18 22:27:28 |
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Basic information
Public title
Association between Acute Respiratory Acidosis and Hyperkalemia During Esophageal Cancer Surgery in the Prone Position: A Retrospective Observational Study
Acronym
PRO-K study
Scientific Title
Association between Acute Respiratory Acidosis and Hyperkalemia During Esophageal Cancer Surgery in the Prone Position: A Retrospective Observational Study
Scientific Title:Acronym
PRO-K study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prone positioning has become an increasingly common approach for thoracoscopic esophageal cancer surgery to facilitate surgical exposure. It has been associated with better surgical outcomes and improved perioperative safety compared to the classical lateral decubitus position. However, it may significantly impact ventilation. Partial lung collapse and intrathoracic insufflation of carbon dioxide (CO2), commonly used in these procedures, may contribute to abrupt shifts in respiratory physiology and acid-base balance. Clinically, transient elevations in serum potassium levels associated with acute respiratory acidosis are often observed during these surgeries. While acidosis is generally known to affect potassium distribution, respiratory acidosis is typically considered to cause only mild increases in serum potassium compared to metabolic acidosis. However, recent clinical reports challenge this view in the setting of critical illness; for instance, Pathak and Nanda described cases of severe, refractory hyperkalemia in COVID-19 patients where acute respiratory acidosis was identified as a major contributing factor. Nevertheless, the combination of prone positioning, ventilatory compromise, and CO2 insufflation may alter the expected
physiological response. This study aims to investigate whether acute elevations in arterial carbon dioxide partial pressure (PaCO2) during esophageal cancer surgery in the prone position are associated with significant increases in serum potassium levels, and to explore the clinical implications of these changes. This research may contribute to establishing safer ventilation strategies and optimizing electrolyte management during these procedures.
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Basic objectives2
Others
Basic objectives -Others
To identify risk factors for hyperkalemia during esophagectomy in the prone position using multivariate analysis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The mean difference in serum potassium levels between the baseline (supine) and the intraoperative (prone) timepoints.
Key secondary outcomes
Factors Associated with Change in Serum Potassium (change in K+)
Correlation between the change in K+ and changes in physiological variables (e.g., PaCO2, lactate).
Multivariable analysis to identify independent factors associated with the magnitude of the change in K+.
Sensitivity Analysis of the Primary Outcome
Re-evaluation of the primary outcome after excluding cases with severe metabolic acidosis.
Exploratory and Clinical Analyses
Exploratory analysis of risk factors for clinically significant hyperkalemia (serum K+ > 5.0 mEq/L).
Subgroup analyses based on preoperative renal function and bronchial blocker usage.
Descriptive analysis of other acid-base parameters (e.g., HCO3-, BE).
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 thoracoscopic esophagectomy (including robot-assisted surgery) in the prone position.
Key exclusion criteria
Patients undergoing chronic dialysis
Patients with severe electrolyte abnormalities (defined as a preoperative serum potassium level of 5.0 mEq/L or higher)
Patients who received intraoperative massive transfusion (defined as having received a transfusion for a blood loss of 2000 ml or more)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Sakura |
| Middle name | |
| Last name | Okamoto |
Organization
Aichi Medical University Hospital
Division name
Department of Anesthesiology
Zip code
4801195
Address
1-1 Karimatamata, Yazako, Nagakute, Aichi, Japan
TEL
0561-62-3311
sokamotoanes@gmail.com
Public contact
Name of contact person
| 1st name | Sakura |
| Middle name | |
| Last name | Okamoto |
Organization
Aichi Medical University Hospital
Division name
Department of Anesthesiology
Zip code
4801195
Address
1-1 Karimatamata, Yazako, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
sokamotoanes@gmail.com
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
Aichi Medical University Ethics Committee
Address
1-1 Karimatamata, Yazako, Nagakute, Aichi, Japan
Tel
0561-62-3311
sokamotoanes@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
愛知医科大学病院、愛知県がんセンター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 19 | 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
150
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a two-center, retrospective observational study. The study will include adult patients who underwent thoracoscopic esophagectomy in the prone position at Aichi Medical University Hospital and Aichi Cancer Center between 2022 and 2024. Medical and anesthesia records will be retrospectively reviewed to evaluate the association between intraoperative acute respiratory acidosis and changes in serum potassium levels.
The primary outcome is the mean change in serum potassium level from the baseline (supine position) to the intraoperative period (prone position). Secondary outcomes include exploring physiological factors associated with the change in serum potassium (e.g., PaCO2), identifying risk factors for clinically significant hyperkalemia, and conducting subgroup analyses based on factors such as preoperative renal function.
Management information
Registered date
| 2025 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067264
