Does a Central Venous Line Reduce Perioperative Fluid Administration?
In High Risk Patients Undergoing Elective Colorectal Resection, Does Routine Placement of a Central Venous Catheter Reduce Peri-operative Fluid Administration in Theatre and the Critical Care Unit?
調査の概要
詳細な説明
There are several indications for elective central venous cannulation in major colorectal surgery, particularly in those at a higher risk of morbidity and mortality. These include: the ability to infuse certain vasoactive medications, monitor central venous pressure, allow for frequent blood sampling, and provide a route of access for total parenteral nutrition(1). Furthermore, there has been a great deal of recent interest in whether there are improved outcomes with restrictive as opposed to liberal fluid therapy in major abdominal surgery(2), and, similarly, with individualised, rather than generic, blood pressure management in major surgery(3). However, there have been no major studies to date examining whether the simple act of electively inserting a central venous catheter prior to the start of surgery influences the volume of fluid infused and the use of vasopressors perioperatively.
The RELIEF trial reported that modestly liberal perioperative fluid regimens conferred no greater disability-free survival benefit over restrictive regimens, but are likely to reduce rates of acute kidney injury(2). This contrasts with the restrictive protocols championed by various Enhanced Recovery After Surgery (ERAS) programs(4). Previous works have suggested that not only does adherence to ERAS principles lead to superior patient outcomes, but some have gone further in identifying restriction of intravenous fluids perioperatively to be one of the few interventions that independently predicts a better outcome(5). One of the advantages of central venous catheterisation is the ability to administer drugs in smaller volumes of fluid. Therefore, given the intensity of the debate surrounding restrictive and liberal regimens, it should be investigated whether the availability of central venous access impacts upon the volumes of fluid infused.
Furthermore, central venous catheterisation is unlikely just to have an impact via the avoidance of inadvertent larger volume infusion, which is sometimes seen with drug administration through a peripheral line. The RELIEF trial reported that the patient cohort managed with a restrictive fluid regimen were more likely to receive vasopressor support, compared with those receiving a liberal regimen(2). The presence of a central venous catheter enables the use of potent vasopressor agents, such as noradrenaline, which will further influence fluid administration, by introducing a second therapeutic option for correcting perioperative hypotension. The importance of 'tight' blood pressure control has been demonstrated by the INPRESS trial, which showed a reduction in post-operative organ dysfunction with individualised blood pressure management, over standard management strategies(3). This is of particular importance, as evidence has shown that cardiac output-directed fluid therapy should not lead to 'excessive fluid administration, but may lead to a more individualised approach to achieving the correct dose of fluid'(6), and may require concomitant use of vasoactive agents.
Thus, the investigators have set out to investigate whether the elective insertion of a central venous catheter prior to the start of major colorectal surgery, influences the volumes, and types, of fluid infused, as well as the use and mean dose of vasopressor agents, intra-operatively and for the first 12 hours post-operatively.
- Smith, RN, et al., 'Central venous catheters', BMJ 2013; 347:f6570
- Myles, PS, et al., 'Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery', N Engl J Med 2018; 378:24
- Futier, E, et al., 'Effect of Individualised vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery', JAMA 2017; 318(14):1346
- Feldheiser, A, et al., 'Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice', Acta Anaesthesiologica Scandinavia 2016, 60:289
- Gustafsson, UO, et al., 'Adherence to the Enhanced Recovery After Surgery Protocol and Outcomes After Colorectal Cancer Surgery', Arch Surg 2011; 146(5):571
- Pearse, RM, et al., 'Effect of a Perioperative Cardiac Output- Guided Haemodynamic Therapy Algorithm on Outcomes Following Major Gastrointestinal Surgery', JAMA 2014; 311(21):2181
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
London、イギリス、E11 1NR
- Whipps Cross Hospital, Barts Health NHS Trust
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
The inclusion criteria will be all adult patients presenting for elective major colorectal surgery (resection), whom are to be electively admitted to critical care directly from theatre.
Exclusion Criteria:
- Patients under 18 years of age
- Patients undergoing emergency surgery
- Those not admitted electively to critical care directly from theatre
- Those patients that do not undergo any bowel resection
- Patients in whom central venous catheter insertion is as an emergency peri- operatively
- Patients refusing/unable to give valid informed consent
研究計画
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 |
|---|---|
|
No CVC inserted
Patients undergoing major elective colorectal resection without central venous catheter inserted pre-operatively
|
|
|
CVC inserted
Patients undergoing major elective colorectal resection with a central venous catheter inserted pre-operatively
|
Insertion of a central venous catheter insertion pre-operatively (electively)
|
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 |
|---|---|---|
|
Volume of intravenous fluid infused intra-operatively
時間枠:Intra-operatively (from induction to leaving theatre)
|
To assess whether the presence of a central venous catheter influences the volume of intravenous fluid infused intra-operatively
|
Intra-operatively (from induction to leaving theatre)
|
|
Volume of intravenous fluid infused post-operatively
時間枠:The first 12 hours post-operatively (commencing from the arrival on the critical care unit, until the end of the 12th post-operative hour)
|
To assess whether the presence of a central venous catheter influences the volume of intravenous fluid infused post-operatively
|
The first 12 hours post-operatively (commencing from the arrival on the critical care unit, until the end of the 12th post-operative hour)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of Intensive Care Unit Stay
時間枠:From admission to intensive care, until stepdown to the ward (and until the expected end of study on 30th April 2020)
|
Does the presence of a central venous catheter alter length of post-operative stay on the Intensive Care Unit
|
From admission to intensive care, until stepdown to the ward (and until the expected end of study on 30th April 2020)
|
|
Volume of blood product infused peri-operatively
時間枠:From induction of anaesthesia until the end of the 12th post-operative hour
|
To assess whether the presence of a central venous catheter influences the volume of blood products infused peri-operatively
|
From induction of anaesthesia until the end of the 12th post-operative hour
|
|
Mean dose of required vasopressor agents
時間枠:From induction of anaesthesia until the end of the 12th post-operative hour
|
To assess whether the presence of a central venous catheter influences the mean dose of any required vasopressor agents peri-operatively
|
From induction of anaesthesia until the end of the 12th post-operative hour
|
|
Use of cardiac output (flow-monitoring) equipment
時間枠:From induction of anaesthesia until the end of the 12th post-operative hour
|
To assess whether the presence of a central venous catheter, and any ensuing fluid and blood pressure management strategies, influence the use of cardiac output monitoring equipment peri-operatively
|
From induction of anaesthesia until the end of the 12th post-operative hour
|
|
Length of hospital stay
時間枠:From the day of the procedure until discharge from the hospital (and until the expected end of study on 30th April 2020)
|
To assess whether the presence of a central venous catheter influences the total post-operative length of stay
|
From the day of the procedure until discharge from the hospital (and until the expected end of study on 30th April 2020)
|
協力者と研究者
捜査官
- スタディディレクター:David Melia, MBBS、Barts & The London NHS Trust
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 012593
- 19/LO/0099 (その他の識別子:HREC)
- 252375 (その他の識別子:IRAS)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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