連続的腎代替療法を受けている急性腎障害患者における、修正静脈過剰超音波検査法に基づく体液バランス管理と標準的治療の比較 (mVExUS-CRRT)
急性腎障害患者における持続的腎代替療法中の修正静脈過剰超音波検査に基づく体液バランス管理と標準治療の比較：多施設共同ランダム化比較試験
The goal of this randomised controlled trial is to compare the cumulative fluid balance over the first 72 h following inclusion guided by mVExUS versus standard of care in critically ill patients with acute kidney injury receiving CRKT . It will also compare the proportion of CRRT-related complications-including intradialytic hypotension and arrhythmias-between patients managed with mVExUS-guided fluid management and those receiving standard care.
The main questions it aims to answer are:
Does fluid removal rate guided by mVExUS will reduce cumulative fluid balance over the course of the first 72 h of CRRT in ICU patients compared to standard care
Participants will:
Get fluid assessment by mVExUS protocol or a strandard care every 8 hours for 72 hours
調査の概要
状態
詳細な説明
After enrollment, the participants have to be randomized within 1 h. In the intervention arm, mVExUS has to be performed every 24 hours until 72 hours after enrollment. Participants with profile A will have UFNET 0 mL/hr with target fluid balance 0 to +500 mL/day. Patients with profile B will have UFNET 0-20 mL/hr with target fluid balance 0 to -500 mL/day. Patients with profile C will have UFNET 20-40 mL/hr with target fluid balance -500 to -1000 mL/day. Patients with profile D will have UFNET 40-100 mL/hr with target fluid balance neg >1000 mL/day.
This intervention will be combined with serial lactate monitoring in which lactate levels will be measured every 8 h. When the lactate level rises more than 2 or if there is presence of HIRRT (tachycardia, hypotension, mottling or drop in cardiac index), passing leg raising or mini-fluid challenge (crystalloid fluid bolus 200 mL) will be performed to assess fluid responsiveness. If there is fluid responsiveness, UFNET will be stopped. Once lactate is normalized or episode of HIRRT resolved, the UFNET strategy has to be restored.
The CRRT technique (haemodialysis, haemofiltration, haemodiafiltration) will be left at the discretion of the treating team. CRRT dose (i.e. dialysate or reinfusion fluids flow rate) will be prescribed at 25-30 ml/kg/hr according to the KDIGO guideline. CRRT dose and UFNET will be indexed to the patient's body weight, and in patients with a body mass index at 30 kg/m2, to the adjusted body weight (calculated as ideal body weight to which will be added 40% of the difference between the actual body weight and the ideal body weight - Du Bois formula). Choice of extra-corporeal circuit anticoagulation (heparin, citrate or none) and implantation site of CRRT catheters will be left at the discretion of the treating physician.
Vasopressors will be titrated as per unit-based protocols to maintain the mean arterial pressure within the bounds prescribed by the physician in charge (most frequently between 65 and 75 mmHg). Indications and category of vasopressors and inotropes will be left at the discretion of the treating team. The diuretic will be stopped once the patient is enrolled.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：thanphisit trakarnvanich, Bachelor's Degree
- 電話番号：+66896996830
- メール：thanphisit2@hotmail.com
研究場所
-
-
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Bangkok、タイ、10330
- 募集
- King Chulalongkorn Memorial Hospital
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コンタクト：
- Nuttha Lumlertgul, PhD
- 電話番号：+66896996830
- メール：nlumlertgul@gmail.com
-
Bangkok、タイ、10300
- まだ募集していません
- Vajira Hospital, Navamindradhiraj University
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コンタクト：
- Thanphisit Trakarnvanich
- 電話番号：+66896996830
- メール：thanphisit2@hotmail.com
-
-
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
説明
Inclusion Criteria:
- Adults (≥ 18 years of age)
- Admitted to ICU
- Acute kidney injury by KDIGO criteria
- Initiated CRRT by at least one of the following indications for RRT initiation:
- Serum potassium ≥ 6.0 mmol/L, or
- pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L, or
- Evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload, or
- Persistent severe AKI (sCr remains > 50% the value recorded at randomization) for > 72 hours from randomization
- Participants giving informed consent
Exclusion Criteria:
- Refuse to participate
- Previous diagnosis of end-stage kidney disease (ESKD) currently on kidney replacement therapy
- Kidney transplant recipient
- Receive RRT before ICU admission within 90 days
- Structural kidney diseases which will interfere with intrarenal doppler ultrasound e.g. renal artery stenosis, autosomal dominant polycystic kidney disease
- Patients with previously known conditions that interfere with portal doppler assessment, namely liver cirrhosis, severe tricuspid regurgitation with structural heart disease or massive ascites.
- Underlying disease process with a life expectancy less than 90 days
- Pregnancy
- Severe cardiac rhythm disturbances (tachyarrhythmia, supraventricular tachycardia)
- Intra-cardiac shunts; Ventricle septal defect, patent foramen ovale, atrial septal defect
- Aortic aneurysm
- Intra-abdominal hypertension (intraabdominal pressure ≥20 mmHg)
- Expected life expectancy <48 hours
- Receiving extracorporeal membrane oxygenation (ECMO)
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：標準ケア
|
|
|
アクティブコンパレータ：mVExUSガイド下輸液管理
|
In the intervention arm, mVExUS has to be performed every 24 hours until 72 hours after enrollment. Participants with profile A will have UFNET 0 mL/hr with target fluid balance 0 to +500 mL/day. Patients with profile B will have UFNET 0-20 mL/hr with target fluid balance 0 to -500 mL/day. Patients with profile C will have UFNET 20-40 mL/hr with target fluid balance -500 to -1000 mL/day. Patients with profile D will have UFNET 40-100 mL/hr with target fluid balance neg >1000 mL/day. This intervention will be combined with serial lactate monitoring in which lactate levels will be measured every 8 h. When the lactate level rises more than 2 or if there is presence of HIRRT (tachycardia, hypotension, mottling or drop in cardiac index), passing leg raising or mini-fluid challenge (crystalloid fluid bolus 200 mL) will be performed to assess fluid responsiveness. If there is fluid responsiveness, UFNET will be stopped. Once lactate is normalized or episode of HIRRT resolved, the UFNET strat |
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 |
|---|---|---|
|
72-hour cumulative fluid balance between mVExUS-guided management and standard care in critically ill patients with acute kidney injury receiving CRKT.
時間枠：Hour 0, Hour 72
|
In the mVExUS-guided management the fluid removal rate will be guided based on mVExUS ultrasound results. In standard care the fluid removal rate is based on conventionval fluid assessment |
Hour 0, Hour 72
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
mVExUSガイド下輸液管理と標準治療との間の28日および90日死亡率
時間枠：28日、90日
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28日、90日
|
|
AKIサブフェノタイプ（アンジオポエチン-1、アンジオポエチン-2、および可溶性TNF受容体-1による分類）と、CRRTを受けている急性腎障害の重症患者における死亡リスクとの関連
時間枠：28日
|
28日
|
|
mVExUSガイド下輸液管理を受けた患者と標準的治療を受けた患者との間の、透析中低血圧や不整脈を含むCRRT関連合併症の割合
時間枠：0時間目、72時間目
|
0時間目、72時間目
|
|
急性腎障害を有する重症患者における持続的腎代替療法（CRRT）施行時の体液貯留および正味限外濾過経過の差異パターンと28日死亡率の差異との関連
時間枠：28日
|
28日
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 0449/2568
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
The datasets used and/or analysed will be available from the corresponding author on reasonable request.
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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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