The effects of Limited Infusion rate of Fluid in the Early resuscitation of Sepsis on Syndecan-1 Shedding: a randomized controlled trial

Phase 2

Completed

• Conditions: SepsisSepsis- induced hypoperfusion; Sepsis, glycocalyx, syndecan- 1, fluid bolus, fluid resuscitation

• Registration Number: TCTR20181010001
• Lead Sponsor: Jutamas Saoraya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-10
• Study Completion: 2020-05-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1.adults aged 18 or over
2.with suspected sepsis according to the sepsis-3 definition identified by [18]
a.suspected infection with
b.qSOFA ≥ 2/3
i.alteration in mental status
ii.Systolic Blood Pressure (SBP) ≤ 100 mmHg
iii.Respiratory rate (RR) ≥ 22/min
3.and hypoperfusion as by clinician’s decision to use fluid bolus therapy for 30 ml/kg including
a.Systolic Blood Pressure (SBP) < 90 mmHg,
b.MAP < 65 mmHg
c.lactate ≥ 2 mmol/L.

Exclusion Criteria

1.Received resuscitation fluid for more than 500 ml.
2.Severe hypotension (SBP < 70 mmHg)
3.Suspected other main causes of hypoperfusion (obstructive, cardiogenic, hypovolemic such as gastrointestinal hemorrhage)
4.Concurrent acute heart failure or known left ventricular ejection fraction (LVEF) less than 40% or poor LVEF by eyeballing on point of care ultrasound (POCUS)
5.End stage renal disease (ESRD) with chronic RRT
6.Suspected infection from microorganisms other than bacteria
7.Potentially need for immediate surgery in 6 hours
8.Body mass index (BMI) ≥ 30 kg/m2
9.Concurrent acute traumatic brain injury
10.Do-Not-Attempt-Resuscitation (DNAR) order status
11.Transferred from another hospital
12.Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of syndecan-1 level 6 hour serum syndecan-1

Secondary Outcome Measures

Name	Time	Method
lactate clearance 6 hour serum lactate,percentage of patients with MAP >= 65 hour 1 and hour 6 observation,P/F ratio hour 6 Arterial blood gas,all cause mortality day 28, 90 observation and telephone inquiry,Time to death 90 day observation and telephone inquiry,Hospital length of stay 28 day observation,fluid input hour 6 observation,fluid balance 24 and 72 hour observation,organ failure-free day 28 day observation,requirement for intubation, time to intubation, ventilator-free days, development of ARDS 28 day observation,requirement for new renal replaement therapy (RRT), RRT-free days 28 day observation,requirement for vasopressor, time to vasopressor initiation, duration of vasopressor 28 day observation,vasopressor-free day 28 day observation,cardiogenic pulmonary edema 6 hour observation,new arrhythmia 6 hour observation,extravasation of norepinephrine 6 hour observation,early termination of the study protocol and reasons 6 hour observation