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

2026년 7월 10일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

128

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Sisli
      • Istanbul, Sisli, 터키 (Türkiye), 34384
        • 모병
        • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
다른 이름들:
  • 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Serum Lactate Concentration
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Systolic and Diastolic Blood Pressure
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

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스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 11월 15일

기본 완료 (추정된)

2026년 11월 15일

연구 완료 (추정된)

2026년 11월 15일

연구 등록 날짜

최초 제출

2026년 7월 7일

QC 기준을 충족하는 최초 제출

2026년 7월 10일

처음 게시됨 (실제)

2026년 7월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 10일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

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

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아니요

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