NCT06790017

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

January 9, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

elderlyhypothermia

Outcome Measures

Primary Outcomes (1)

  • Perioperative Hypothermia

    Perioperative hypothermia is defined as any core temperature less than 96.8°F (36.0°C)

    1 hour before anesthesia and intraoperative

Secondary Outcomes (2)

  • Frailty

    preoperative

  • Red blood cell distribution width

    1 hour before anesthesia and intraoperative

Study Arms (2)

Low hemoglobin to red cell distribution width ratio (HRR)

Patients whose HRR rate is below 9.97 and are considered frail

Other: body temperature

High hemoglobin to red cell distribution width ratio (HRR)

Patients whose HRR ratio is above 9.97 and are considered non-frail

Other: body temperature

Interventions

Body temperature measurement will be performed in the preoperative and intraoperative periods.

High hemoglobin to red cell distribution width ratio (HRR)Low hemoglobin to red cell distribution width ratio (HRR)

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Etlik City Hospital, Urology Operating Rooms

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 37423632BACKGROUND
  • 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.

    PMID: 34513961BACKGROUND

MeSH Terms

Conditions

Hypothermia

Interventions

Body Temperature

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysiological Phenomena

Study Officials

  • Gokcen KULTUROGLU

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 23, 2025

Study Start

April 9, 2025

Primary Completion

June 1, 2025

Study Completion

June 11, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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.

Locations