CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 211 enrolled
Drug / intervention
Antibiotics +2 moredrug
Likely dose
Not stated in record
Key inclusion· 1
  • Septic shock requiring vasopressor to maintain MAP ≥65 mmHg with serum lactate >2 mmol/L in the absence of hypovolemia
Key exclusion· 11
  • Congestive pulmonary edema or left ventricular ejection fraction ≤40%
  • Known right heart pathologies
  • Marked ascites, significant bowel dilatation, or conditions causing abdominal hypertension
  • Body mass index ≥30 kg/m²

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03020407
NCT03020407N/ACompleted

The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation

Chulalongkorn University·interventional·Posted Jan 13, 2017·Updated Sep 22, 2021

In Brief

A clinical study evaluating IVC Ultrasound-guided, Antibiotics, and 1 other intervention for Septic Shock. Completed, enrolled 211 participants across 1 site.

Detailed Summary

The primary aim of this study is to evaluate the 30-day mortality outcome of the septic shock patients who are treated with ultrasound-assisted fluid management using change of the inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared with those treated with "usual-care" strategy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesThailand
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 13, 2017
Enrollment StartJan 18, 2017
Primary CompletionJun 30, 2020
Study CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.5 years ago

Interventions

IVC Ultrasound-guidedprocedure

IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.

Antibioticsdrug

Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.

Vasopressordrug

The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.