NCT04143035: HERMES

Hemodynamic Resuscitation and Monitoring in Early Sepsis

Status unknown Last updated 24 October 2022

What this trial tests

trial testing No Intervention in Septic Shock in 500 participants. Status unknown.

Timeline

22 October 2019

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Tata Memorial Centre
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	500
Start date	22 October 2019
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	246 locations across India

Drugs / interventions tested

• No Intervention

Conditions studied

• Septic Shock — all drugs for Septic Shock →

Sponsor

Tata Memorial Centre — full company profile →

Who can join

18 and older, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

"Hemodynamic Resuscitation and Monitoring in Early Sepsis (HERMES Study)" involves recording of patient's medical data related to that has been collected as part of his/her routine medical care in ICU.

Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice. The investigators would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, Investigator would like to identify factors associated with improved outcomes and achieving the goals of the sepsis bundles in one, three and six hours.

The objectives of the study is to capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patients presenting with early sepsis and hypotension to Indian ICUs

Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients in a maximum time window of 60 days. A convenience sample of minimum 500 patients presenting to ICU with suspected sepsis and hypotension will be taken.

Each Centre will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled.

This is an ISCCM(Indian Society of Critical Care Medicine) Research Committee funded study. The ISCCM will fund the Principal Investigator for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication. No funding will be given to the investigators from the various participating centers for contributing data.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.