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

10 lipca 2026 zaktualizowane przez: Beyzanur Aydoğdu

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:

  • 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

128

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Sisli
      • Istanbul, Sisli, Turcja (Türkiye), 34384
        • Rekrutacyjny
        • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
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.
Inne nazwy:
  • Active preoperative warming
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Serum Lactate Concentration
Ramy czasowe: 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.
From the preoperative assessment to 24 hours after surgery

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Systolic and Diastolic Blood Pressure
Ramy czasowe: 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.
From the preoperative assessment to 24 hours after surgery
Change in Heart Rate
Ramy czasowe: 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.
From the preoperative assessment to 24 hours after surgery
Change in Body Temperature
Ramy czasowe: 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.
From the preoperative assessment to 24 hours after surgery
Change in Hemoglobin Level
Ramy czasowe: 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.
From the preoperative assessment to 24 hours after surgery
Change in Hematocrit
Ramy czasowe: 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.
From the preoperative assessment to 24 hours after surgery
Change in Serum Osmolality
Ramy czasowe: 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.
From the preoperative assessment to 24 hours after surgery
Length of Intensive Care Unit Stay
Ramy czasowe: Up to 48 hours after surgery
Duration of stay in the intensive care unit, compared between the prewarming and control groups.
Up to 48 hours after surgery
Need for Blood Transfusion
Ramy czasowe: 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.
During the first 48 hours after surgery
Incidence of Postoperative Complications
Ramy czasowe: 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.
From surgery to 24 hours after surgery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 listopada 2025

Zakończenie podstawowe (Szacowany)

15 listopada 2026

Ukończenie studiów (Szacowany)

15 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

7 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 lipca 2026

Pierwszy wysłany (Rzeczywisty)

14 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • CT-ERHO-AR-BA-03
  • E-48670771-514.99-293554897 (Inny identyfikator: PROF. DR. CEMIL TASCIOGLU SEHİR HASTANESİ ETİK KURUL BİRİMİ)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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