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

2026年7月10日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

128

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Sisli
      • Istanbul、Sisli、トルコ(Türkiye)、34384
        • 募集
        • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
他の名前:
  • 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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Serum Lactate Concentration
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Systolic and Diastolic Blood Pressure
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

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スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年11月15日

一次修了 (推定)

2026年11月15日

研究の完了 (推定)

2026年11月15日

試験登録日

最初に提出

2026年7月7日

QC基準を満たした最初の提出物

2026年7月10日

最初の投稿 (実際)

2026年7月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月14日

QC基準を満たした最後の更新が送信されました

2026年7月10日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CT-ERHO-AR-BA-03
  • E-48670771-514.99-293554897 (その他の識別子:PROF. DR. CEMIL TASCIOGLU SEHİR HASTANESİ ETİK KURUL BİRİMİ)

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いいえ

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