UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053677 |
|---|---|
| Receipt number | R000061249 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2024/02/21 |
| Last modified on | 2024/02/22 03:45:02 |
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Basic information
Public title
Comparing the effects of dynamic parameter- to static parameter-guided fluid resuscitation on organ functions in septic patients
Acronym
CEDS-OFIS
Scientific Title
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
Scientific Title:Acronym
SOFA-DUSCIS
Region
| Asia(except Japan) |
Condition
Condition
sepsis
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the clinical outcomes between the ultrasound (US) of dynamic IVC variation-guided and static CVP-guided fluid resuscitation in patients with sepsis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in the SOFA score from the diagnosis of sepsis to 72 hours later
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Thiti |
| Middle name | |
| Last name | Sricharoenchai |
Organization
Thammasat University
Division name
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine
Zip code
12120
Address
99/209 Moo 18, Paholyotin Road, Klongnueng, Klongluang, Pathum Thani, Thailand
TEL
+6629269794
thiti_x@tu.ac.th
Public contact
Name of contact person
| 1st name | Thiti |
| Middle name | |
| Last name | Sricharoenchai |
Organization
Thammasat University
Division name
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine
Zip code
12120
Address
99/209 Moo 18, Paholyotin Road, Klongnueng, Klongluang, Pathum Thani, Thailand
TEL
+6629269794
Homepage URL
thiti_x@tu.ac.th
Sponsor or person
Institute
Thammasat University
Institute
Department
Personal name
Funding Source
Organization
Thammasat University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Research Ethics Committee of Thammasat University No.1 (Faculty of Medicine)
Address
99/209 Moo 18, Paholyotin Road, Klongnueng, Klongluang, Pathum Thani, Thailand 12120
Tel
+6629269704
ec.medtu@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
104
Results
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.
Results date posted
| 2024 | Year | 02 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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.
Participant flow
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.
Adverse events
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.
Outcome measures
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.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061249
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