Nephrectomy / MethodsNCT07702487
Effect of Preoperative Prewarming on Serum Lactate Levels in Patients Undergoing Elective Nephrectomy
An observational study of Nephrectomy / Methods and Intraoperative Hypothermia, run by Beyzanur Aydoğdu at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nephrectomy / Methods, Intraoperative Hypothermia, Hyperlactatemia
- What is being tested?
- Preoperative active warming (prewarming)
- Type of treatment
- Medical device
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Scheduled for elective nephrectomy
- Adults aged 18-90 years
- ASA (American Society of Anesthesiologists) physical status classification I-III
- Signed informed consent form
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Istanbul, Sisli, 34384
Mehmet Mutlu, Assoc. Prof., +905363458888, drmmutlu@gmail.com
About this study
Official title: Effect of Preoperative Active Prewarming on Serum Lactate Levels and Perioperative Outcomes in Patients Undergoing Elective Nephrectomy: A Prospective Observational Study
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Preoperative active warming (prewarming)
- Keywords
- prewarming, Preoperative warming, Perioperative hypothermia, serum lactate, Nephrectomy, Anesthesia, Intensive care unit, Postoperative complications
- Medical subject headings
- Hyperlactatemia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative active warming (prewarming)Device
Also called Active preoperative warming
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the preoperative assessment to 24 hours after surgery
Secondary outcomes (9)
Change in Systolic and Diastolic Blood Pressure
Changes in systolic and diastolic arterial blood pressure from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.
Measured: From the preoperative assessment to 24 hours after surgery
Change in Heart Rate
Change in heart rate from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.
Measured: From the preoperative assessment to 24 hours after surgery
Change in Body Temperature
Change in body temperature from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.
Measured: From the preoperative assessment to 24 hours after surgery
Change in Hemoglobin Level
Change in hemoglobin concentration from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.
Measured: From the preoperative assessment to 24 hours after surgery
Change in Hematocrit
Change in hematocrit from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.
Measured: From the preoperative assessment to 24 hours after surgery
Change in Serum Osmolality
Change in serum osmolality from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.
Measured: From the preoperative assessment to 24 hours after surgery
Length of Intensive Care Unit Stay
Duration of stay in the intensive care unit, compared between the prewarming and control groups.
Measured: Up to 48 hours after surgery
Need for Blood Transfusion
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.
Measured: During the first 48 hours after surgery
Incidence of Postoperative Complications
Presence and type of postoperative complications (respiratory, cardiac, renal, infectious, hematologic, or other), compared between the prewarming and control groups.
Measured: From surgery to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Nov 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrectomy / MethodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beyzanur Aydoğdu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beyzanur Aydoğdu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702487
- Sponsor's protocol ID
- CT-ERHO-AR-BA-03
- Other IDs
- E-48670771-514.99-293554897
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Active Prewarming on Serum Lactate Levels and Perioperative Outcomes in Patients Undergoing Elective Nephrectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07702487
- Acronym / sponsor ID
- CT-ERHO-AR-BA-03
- Keywords
- prewarming, Preoperative warming, Perioperative hypothermia, serum lactate, Nephrectomy, Anesthesia, Intensive care unit, Postoperative complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Beyzanur AydoğduUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prewarming Group | – | Device: Preoperative active warming (prewarming)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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Scheduled for elective nephrectomy
- Adults aged 18-90 years
- ASA (American Society of Anesthesiologists) physical status classification I-III
- Signed informed consent form
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative active warming (prewarming)Also: Active preoperative warmingApplication 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. | Device | Prewarming Group |
Primary outcome
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.
9 secondary outcomes
Change in Systolic and Diastolic Blood Pressure
Time frame: From the preoperative assessment to 24 hours after surgery
Change in Heart Rate
Time frame: From the preoperative assessment to 24 hours after surgery
Change in Body Temperature
Time frame: From the preoperative assessment to 24 hours after surgery
Change in Hemoglobin Level
Time frame: From the preoperative assessment to 24 hours after surgery
Change in Hematocrit
Time frame: From the preoperative assessment to 24 hours after surgery
Change in Serum Osmolality
Time frame: From the preoperative assessment to 24 hours after surgery
Length of Intensive Care Unit Stay
Time frame: Up to 48 hours after surgery
Need for Blood Transfusion
Time frame: During the first 48 hours after surgery
Incidence of Postoperative Complications
Time frame: From surgery to 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrectomy / Methods and Intraoperative Hypothermia, run by Beyzanur Aydoğdu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Lactate Concentration (time frame: From the preoperative assessment to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.