Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07702487

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Sisli, 34384, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet Mutlu, Assoc. Prof.

CONTACT

[email protected]

+905363458888

About this study

Nephrectomy is a major surgical procedure, performed via open or laparoscopic approaches, that is associated with a substantial physiological stress response. Reduced tissue perfusion and increased anaerobic metabolism during major surgery can raise serum lactate levels, and maintaining perioperative metabolic stability is an important goal in these patients.

Prewarming refers to active warming of a patient's body surface before induction of anesthesia, with the aim of reducing intraoperative core-temperature drop and its downstream effects on tissue perfusion and oxygenation. Clinical practice regarding the use and duration of prewarming varies among anesthesiologists, and there is no fixed institutional protocol dictating whether, or for how long, it should be applied.

This is a prospective, single-center, observational study conducted over a one-year period. Consecutive adult patients undergoing elective nephrectomy who meet the eligibility criteria will be enrolled and followed as part of routine clinical care (see Eligibility Criteria for full details). Whether a given patient receives prewarming, and for how long (typically 10-15 minutes when used), is determined solely by the anesthesia team providing care in the operating room; the study does not intervene in this clinical decision or modify usual care in any way. Outcomes will be compared between patients who receive prewarming and those who do not.

For each patient, a range of preoperative and postoperative physiological and laboratory parameters is recorded as part of routine perioperative monitoring (see Outcome Measures for the specific parameters and their timing). In addition, length of stay in the intensive care unit, need for blood transfusion, and the occurrence and type of postoperative complications are documented. All data are obtained from existing anesthesia records, nursing charts, laboratory results, intensive care information systems, and patient files, and are transcribed onto a predefined case report form; the study does not add any invasive procedures, blood draws, or deviations from routine clinical protocol.

Continuous variables will be compared between the prewarming and control groups using the independent-samples t-test or Mann-Whitney U test, as appropriate, and categorical variables will be compared using the chi-square test or Fisher's exact test. Regression analysis will be used to examine associations between prewarming and outcomes. A p-value <0.05 will be considered statistically significant. A power analysis (G*Power v3.1.9.2), assuming a medium effect size (Cohen's d=0.5) for the primary between-group lactate comparison, indicated that at least 64 participants per group (128 total) would be needed to achieve 80% power at α=0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: Active preoperative warming

Primary outcomes

  1. Change in Serum Lactate Concentration

    Time frame: From the preoperative assessment to 24 hours after surgery

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

Secondary outcomes

  1. Change in Systolic and Diastolic Blood Pressure

    Time frame: From the preoperative assessment to 24 hours after surgery

    Changes in systolic and diastolic arterial blood pressure from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.

  2. Change in Heart Rate

    Time frame: From the preoperative assessment to 24 hours after surgery

    Change in heart rate from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.

  3. Change in Body Temperature

    Time frame: From the preoperative assessment to 24 hours after surgery

    Change in body temperature from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.

  4. Change in Hemoglobin Level

    Time frame: From the preoperative assessment to 24 hours after surgery

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

  5. Change in Hematocrit

    Time frame: From the preoperative assessment to 24 hours after surgery

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

  6. Change in Serum Osmolality

    Time frame: From the preoperative assessment to 24 hours after surgery

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

  7. Length of Intensive Care Unit Stay

    Time frame: Up to 48 hours after surgery

    Duration of stay in the intensive care unit, compared between the prewarming and control groups.

  8. Need for Blood Transfusion

    Time frame: During the first 48 hours after surgery

    Proportion of patients requiring blood transfusion and the total number of units transfused during the first 48 hours after surgery, compared between the prewarming and control groups.

  9. Incidence of Postoperative Complications

    Time frame: From surgery to 24 hours after surgery

    Presence and type of postoperative complications (respiratory, cardiac, renal, infectious, hematologic, or other), compared between the prewarming and control groups.

Sponsors and collaborators

Lead sponsor

Beyzanur Aydoğdu

Other

Registry information

Official study title

Effect of Preoperative Active Prewarming on Serum Lactate Levels and Perioperative Outcomes in Patients Undergoing Elective Nephrectomy: A Prospective Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.