UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
Comparing the effects of dynamic parameter- to static parameter-guided fluid resuscitation on organ functions in septic patients

一般向け試験名略称/Acronym

日本語

英語
CEDS-OFIS

科学的試験名/Scientific Title

日本語

英語
Comparison in SOFA score between dynamic ultrasound-guidance and static measurement of central venous pressure for fluid resuscitation in patients with septic shock at Thammasat University Hospital

科学的試験名略称/Scientific Title:Acronym

日本語

英語
SOFA-DUSCIS

試験実施地域/Region

アジア（日本以外）/Asia(except Japan)

対象疾患名/Condition

日本語

英語
sepsis

疾患区分1/Classification by specialty

集中治療医学/Intensive care medicine

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語

英語
To compare the clinical outcomes between the ultrasound (US) of dynamic IVC variation-guided and static CVP-guided fluid resuscitation in patients with sepsis

目的2/Basic objectives2

安全性・有効性/Safety,Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語

英語
change in the SOFA score from the diagnosis of sepsis to 72 hours later

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
SOFA score at 72 hours after the diagnosis of sepsis, change in the SOFA score from the diagnosis of sepsis to 7 days later, proportion of patients receiving vasopressor, duration of vasopressor, and incidence of pulmonary edema in 7 days after the diagnosis of sepsis

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

試験参加者がブラインド化されている単盲検/Single blind -participants are blinded

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

はい/YES

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

施設を考慮していない/Institution is not considered as adjustment factor.

ブロック化/Blocking

はい/YES

割付コードを知る方法/Concealment

封筒法/Numbered container method

群数/No. of arms

2

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

手技/Maneuver

介入1/Interventions/Control_1

日本語

英語
Intervention: dynamic IVC variation-guided fluid resuscitation
1. Patients were categorized into mechanical ventilation (MV) and spontaneous breathing (SB) subgroups.
2. MV patients were measured by ultrasound for IVC distensibility index with a value of <18% and >=18% being treated as fluid non-responsiveness, and fluid responsiveness, respectively. SB patients were measured by ultrasound for IVC collapsibility index with a value of <50% and >=50% being treated as fluid non-responsiveness and fluid responsiveness, respectively.
3.Crystalloid (mostly 0.9%NaCl solution) 500 milliliters (mL) in 15 minutes (min) was administered intravenously to fluid responsive patients, and IVC distensibility index or IVC collapsibility index measurements were done cyclically and repeatedly until fluid non-responsiveness.
4. Fluid non-responsive patients who remained hypotensive (MAP <65 mmHg) received intravenous vasopressor.
5. All patients received standard treatment with intensive monitoring for 6 hours, and were tracked until shock resolution and discharge, transfer or death within 30 days.

介入2/Interventions/Control_2

日本語

英語
Control: static CVP-guided fluid resuscitation
1. Patients had a central venous catheter inserted for initial CVP measurement with a CVP value of <8 and >=8 mmHg being treated as responsiveness and non-responsiveness, respectively.
2. Fluid responsive patients received crystalloid (mostly 0.9%NaCl solution) intravenously 500 mL in 15 min and CVP measurement cyclically and repeatedly until fluid non-responsiveness.
3. Fluid non-responsive patients who remained hypotensive (MAP <65 mmHg) received intravenous vasopressor.
4. All patients received standard treatment with intensive monitoring for 6 hours, and were tracked until shock resolution and discharge, transfer or death within 30 days.

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

18

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
1) age of >=18 years
2) suspected infection
3) SOFA score of >=2
4) systolic blood pressure (SBP) <90mmHg or SBP decrease > 40 mmHg from the original level or mean arterial pressure (MAP) <70 mmHg
5) requirement of intravenous fluid to maintain stable hemodynamics

除外基準/Key exclusion criteria

日本語

英語
1) pregnancy
2) pulmonary edema due to cardiovascular diseases
3) inability to be in a supine position, e.g., spine deformities
4) difficult or inaccurate US measurement of IVC diameter, e.g., IVC compression from any causes
5) limitation of central venous catheterization e.g., structural abnormalities of internal jugular vein or superior vena cava

目標参加者数/Target sample size

104

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	Thiti
ミドルネーム
姓	Sricharoenchai

所属組織/Organization

日本語

英語
Thammasat University

所属部署/Division name

日本語

英語
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine

郵便番号/Zip code

12120

住所/Address

日本語

英語
99/209 Moo 18, Paholyotin Road, Klongnueng, Klongluang, Pathum Thani, Thailand

電話/TEL

+6629269794

Email/Email

thiti_x@tu.ac.th

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名	Thiti
ミドルネーム
姓	Sricharoenchai

組織名/Organization

日本語

英語
Thammasat University

部署名/Division name

日本語

英語
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine

郵便番号/Zip code

12120

住所/Address

日本語

英語
99/209 Moo 18, Paholyotin Road, Klongnueng, Klongluang, Pathum Thani, Thailand

電話/TEL

+6629269794

試験のホームページURL/Homepage URL

Email/Email

thiti_x@tu.ac.th

機関名/Institute

日本語
その他

英語
Thammasat University

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Thammasat University

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

海外/Outside Japan

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語

英語
The Human Research Ethics Committee of Thammasat University No.1 (Faculty of Medicine)

住所/Address

日本語

英語
99/209 Moo 18, Paholyotin Road, Klongnueng, Klongluang, Pathum Thani, Thailand 12120

電話/Tel

+6629269704

Email/Email

ec.medtu@gmail.com

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2024

年

02

月

21

日

プロトコル掲載URL/URL releasing protocol

N/A

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

N/A

組み入れ参加者数/Number of participants that the trial has enrolled

104

主な結果/Results

日本語

英語
Of 104 patients, 52 in each group had comparable characteristics. Median(IQR) SOFA change in 72 hours were -2(-3.5 to 5) vs. -1(-3 to 3.5) in dynamic IVC vs static CVP groups, p=0.87. SOFA at 72 hours and SOFA change in 7 days were 5(2 to 13) vs. 7(3.5 to 13), p=0.29, and -2(-3.5 to 13) vs. -3(-4 to 1.5), p=0.18, and pulmonary edema in 7 days were 11.5% vs. 13.5%, p=0.77; while vasopressor receivers were 82.7% vs. 96.2%, p=0.03, vasopressor durations were 0.9(0.7 to 1.6) vs. 1.5(1.1 to 2.8) days, p<0.01.

主な結果入力日/Results date posted

2024

年

02

月

21

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語
Out of 249 patients screened for eligibility criteria, 104 cases were included in this study. Fifty-two cases were assigned to the dynamic IVC variation group and the other 52 cases in the static CVP group. The baseline characteristic data between the two groups were not different for age, sex, BMI, APACHE II, underlying diseases, sources of infection, physiological variables, time from diagnosis of sepsis to starting antibiotics, amount of IV fluid administration in 72 hours, and ICU admission. However, the initial SOFA score in the dynamic IVC variation group was marginally lower than the static CVP group.

参加者の流れ/Participant flow

日本語

英語
All recruited patients were stratified by Acute Physiology and Chronic Health Evaluation II (APACHE II) of <25 or >=25, then allocated via a sealed envelopeTM program with blocks of 2 and 4 to either dynamic IVC variation-guided or static CVP-guided group. Eventually, 52 patients were allocated to each group. All patients received fluid resuscitation, intensive monitoring for 6 hours, and were followed until shock recovery, transfer or death within 30 days.

有害事象/Adverse events

日本語

英語
The incidence of pulmonary edema in 7 days was 11.5% in dynamic IVC variation-guided group vs. 13.5% in static CVP-guided group, p=0.77.

評価項目/Outcome measures

日本語

英語
The study found no significant differences between both groups in terms of the change in the medians (IQRs) of SOFA score from the diagnosis of sepsis to 72 hours later and 7 days later, the median (IQR) of SOFA score at 72 hours, or the incidence of pulmonary edema within 7 days after the diagnosis of sepsis. However, the proportion of patients receiving vasopressor and the median (IQR) of the vasopressor duration in the dynamic IVC variation group were significantly less than the static CVP group.

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2019

年

07

月

18

日

倫理委員会による承認日/Date of IRB

2019

年

08

月

09

日

登録・組入れ開始（予定）日/Anticipated trial start date

2019

年

08

月

10

日

フォロー終了(予定)日/Last follow-up date

2020

年

05

月

25

日

入力終了(予定)日/Date of closure to data entry

2020

年

07

月

31

日

データ固定（予定）日/Date trial data considered complete

2020

年

07

月

31

日

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2024

年

02

月

21

日

最終更新日/Last modified on

2024

年

02

月

22

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000061249

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061249