- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06790017
Hemoglobin-to-red Blood Cell Distribution Width Ratio and Hypothermia for Elderly Patient
June 11, 2025 updated by: Gokcen Kulturoglu, Ankara Etlik City Hospital
Temperature Measurement for Transurethral Prostatectomy Surgery in Elderly Patient
As individuals age, they often enter a phase of increased "frailty."
Elderly and frail patients represent a population that requires heightened sensitivity and close monitoring during surgical procedures.
This study aims to investigate the relationship between the Hemoglobin-to-Red Blood Cell Distribution Width (Hb/RDW) ratio and perioperative hypothermia in elderly patients undergoing transurethral prostatectomy.
This is an observational study.
Preoperative blood test results and intraoperative body temperature measurements of the patients will be recorded in our data forms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06170
- Etlik City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Etlik City Hospital, Urology Operating Rooms
Description
Inclusion Criteria:
- Patients who provided informed consent.
- Patients scheduled for transurethral prostatectomy surgery.
- Patients classified as ASA-PS 1, 2, or 3.
- Male patients aged 65 years or older.
- Patients undergoing elective surgery.
- Patients receiving general anesthesia.
Exclusion Criteria:
- Patients who did not provide informed consent.
- Patients undergoing emergency surgery.
- Patients with conditions that disrupt thermoregulation (e.g., intracranial mass, peripheral vascular diseases, sepsis).
- Patients with a body temperature of <34℃ or >38℃ upon arrival at the preoperative waiting room.
- Patients who used heating methods other than the routine cotton cover in the preoperative waiting room.
- Patients who received additional heating methods other than the routinely applied intraoperative hot air blower drapes.
- Patients undergoing surgery under any type of anesthesia other than general anesthesia.
- Patients who were taken out of the operating room while intubated.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Low hemoglobin to red cell distribution width ratio (HRR)
Patients whose HRR rate is below 9.97 and are considered frail
|
Body temperature measurement will be performed in the preoperative and intraoperative periods.
|
|
High hemoglobin to red cell distribution width ratio (HRR)
Patients whose HRR ratio is above 9.97 and are considered non-frail
|
Body temperature measurement will be performed in the preoperative and intraoperative periods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perioperative Hypothermia
Time Frame: 1 hour before anesthesia and intraoperative
|
Perioperative hypothermia is defined as any core temperature less than 96.8°F (36.0°C)
|
1 hour before anesthesia and intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty
Time Frame: preoperative
|
The relationship between hemoglobin to red cell distribution width ratio (HRR) and frailty
|
preoperative
|
|
Red blood cell distribution width
Time Frame: 1 hour before anesthesia and intraoperative
|
The relationship between red blood cell distribution width (RDW) and hypothermia
|
1 hour before anesthesia and intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gokcen KULTUROGLU, Ankara Etlik City Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zhu M, Wei C, Yang X, Huang Y, Xu Y, Xiong Z. Lower haemoglobin-to-red blood cell distribution width ratio is independently associated with frailty in community-dwelling older adults: a cross-sectional study. BMJ Open. 2023 Jul 9;13(7):e069141. doi: 10.1136/bmjopen-2022-069141.
- Qu J, Zhou T, Xue M, Sun H, Shen Y, Chen Y, Tang L, Qian L, You J, Yang R, Liu Y. Correlation Analysis of Hemoglobin-to-Red Blood Cell Distribution Width Ratio and Frailty in Elderly Patients With Coronary Heart Disease. Front Cardiovasc Med. 2021 Aug 27;8:728800. doi: 10.3389/fcvm.2021.728800. eCollection 2021.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2025
Primary Completion (Actual)
June 1, 2025
Study Completion (Actual)
June 11, 2025
Study Registration Dates
First Submitted
January 9, 2025
First Submitted That Met QC Criteria
January 22, 2025
First Posted (Actual)
January 23, 2025
Study Record Updates
Last Update Posted (Actual)
June 12, 2025
Last Update Submitted That Met QC Criteria
June 11, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AESH-EK1-2024-0082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data that support the findings of this study are available on request from the corresponding author, (GK).
The data are not publicly available due to our participants' informed consent forms.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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