Effect of Preoperative Prewarming on Serum Lactate Levels in Patients Undergoing Elective Nephrectomy

NCT07702487 | Recruiting

• 2 other identifiers: CT-ERHO-AR-BA-03E-48670771-514.99-293554897
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn whether warming patients before surgery, called "prewarming," affects blood lactate levels (a marker of how well tissues are getting oxygen) and recovery in adults having planned (elective) kidney removal surgery (nephrectomy). The main questions this study aims to answer are:

• Does prewarming lower the rise in blood lactate seen during and after surgery?
• Does prewarming affect time spent in the intensive care unit (ICU), the need for a blood transfusion, or the rate of complications after surgery? Researchers will compare two groups of adults having this surgery. One group receives brief active warming before anesthesia (the "prewarming" group). The other group does not receive this warming (the "control" group). The anesthesia team decides whether to use prewarming and for how long, as part of routine care; the study does not change this decision. Researchers will compare the two groups to see whether prewarming is linked to lower lactate levels and better recovery. Participants will:
• Receive their usual, routine surgery and anesthesia care
• Have blood pressure, heart rate, body temperature, and blood tests, including lactate, checked before and after surgery, as already done in routine care
• Have their ICU stay, need for blood transfusion, and any complications recorded This study does not add any extra tests, procedures, or blood draws beyond routine clinical care.

Conditions

Nephrectomy / Methods; Intraoperative Hypothermia; Hyperlactatemia

Keywords

prewarming; Preoperative warming; Perioperative hypothermia; serum lactate; Nephrectomy; Anesthesia; Intensive care unit; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• Change in Serum Lactate Concentration

  Change in serum lactate concentration from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.

  From the preoperative assessment to 24 hours after surgery

Secondary Outcomes (9)

• Change in Systolic and Diastolic Blood Pressure

  From the preoperative assessment to 24 hours after surgery

• Change in Heart Rate

  From the preoperative assessment to 24 hours after surgery

• Change in Body Temperature

  From the preoperative assessment to 24 hours after surgery

• Change in Hemoglobin Level

  From the preoperative assessment to 24 hours after surgery

• Change in Hematocrit

  From the preoperative assessment to 24 hours after surgery

Study Arms (2)

Prewarming Group

Patients who receive active preoperative warming, applied by the anesthesia team during operating room preparation, typically for approximately 10-15 minutes before induction of anesthesia, as part of routine clinical care.

Device: Preoperative active warming (prewarming)

Control Group

Patients who do not receive active preoperative warming before induction of anesthesia, per the routine practice of the anesthesia team providing care. All patients receive standard intraoperative and postoperative warming per usual care.

Interventions

Preoperative active warming (prewarming) DEVICE

Application of an active warming device to the patient's body surface during operating room preparation, before induction of anesthesia, for approximately 10-15 minutes at the discretion of the anesthesia team. The decision to apply prewarming, and its duration, follows routine clinical practice and is not standardized by the study protocol.

Also known as: Active preoperative warming

Prewarming Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18-90 years, ASA I-III, undergoing elective nephrectomy (open or laparoscopic) at the study site, enrolled consecutively over a one-year period.

You may qualify if:

• Scheduled for elective nephrectomy
• Adults aged 18-90 years
• ASA (American Society of Anesthesiologists) physical status classification I-III
• Signed informed consent form

You may not qualify if:

• Emergency nephrectomy
• Concurrent additional major surgical procedure planned in the same session
• Age under 18 or over 90 years
• ASA physical status classification IV or higher
• Incomplete preoperative records (missing pre- or postoperative measurement of at least one primary outcome variable)

Sponsors & Collaborators

• Beyzanur Aydoğdu: lead

Study Sites (1)

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Sisli, 34384, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hyperlactatemia; Postoperative Complications

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 14, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)