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Trial record 4 of 4 for:    TAMBE

Hemodynamic Resuscitation and Monitoring in Early Sepsis (HERMES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143035
Recruitment Status : Unknown
Verified October 2019 by Sheila Nainan Myatra, Tata Memorial Centre.
Recruitment status was:  Recruiting
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
Indian Society of Critical Care Medicine
Information provided by (Responsible Party):
Sheila Nainan Myatra, Tata Memorial Centre

Brief Summary:

"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.


Condition or disease Intervention/treatment
Septic Shock Other: No Intervention

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hemodynamic Resuscitation and Monitoring in Early Sepsis
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 14, 2019
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock


Intervention Details:
  • Other: No Intervention
    No Intervention


Primary Outcome Measures :
  1. ICU Mortality [ Time Frame: throughout ICU stay till discharge (up to 2 months) ]
    Overall ICU Mortality due to septic shock with hypotension

  2. Completing the elements of the one hour SSC sepsis bundle in one 1 hour [ Time Frame: 1 hour after admission upto 60 days from the study start date in respective study site (60 days) ]
    Identify factors associated with improved outcomes and fulfilling the goals of the one hour Surviving Sepsis Campaign (SSC) bundles within one, three and six hours in patients with sepsis and septic shock and to identify compliance with the one hour SSC bundle guidelines The Surviving Sepsis Campaign released an updated one-hour sepsis bundle, which combines recommendations listed in the three-hour and six-hour bundles. This includes 5 elements: 1. measuring lactate levels 2. obtaining blood cultures before administering antibiotics 3. administering broad-spectrum antibiotics 4. fluid resuscitation for hypotension or lactate level ≥ 4 mmol/L and 5. use of vasopressors for hypotensive during or after fluid resuscitation to maintain MAP ≥ 65 mm Hg


Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: throughout the hospital stay till discharge in the respective study site (up to 3 months) ]
    Over all mortality during the hospital stay

  2. 28-day mortality [ Time Frame: From ICU admission to 28 days in the respective study site (up to 3 months) ]
    Over all mortality from ICU admission day to till 28 day

  3. Completing the elements of the one hour SSC sepsis bundle in one, three and six hours [ Time Frame: 1 hour, 3 hour and six hour after admission upto 60 days from the study start date in the respective study site (60 days ) ]
    Identify factors associated with improved outcomes and fulfilling the goals of the one hour Surviving Sepsis Campaign (SSC) bundles within one, three and six hours in patients with sepsis and septic shock and to identify compliance with the one hour, three hour and six hour SSC bundle guidelines The Surviving Sepsis Campaign released an updated one-hour sepsis bundle, which combines recommendations listed in the three-hour and six-hour bundles. This includes 5 elements: 1. measuring lactate levels 2. obtaining blood cultures before administering antibiotics 3. administering broad-spectrum antibiotics 4. fluid resuscitation for hypotension or lactate level ≥ 4 mmol/L and 5. use of vasopressors for hypotensive during or after fluid resuscitation to maintain MAP ≥ 65 mm Hg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients presenting to ICU with suspected sepsis and hypotension
Criteria

Inclusion criteria

  1. Adult patients (≥ 18 years old)
  2. Presenting to ICU with suspected sepsis
  3. Presence of hypotension (Systolic BP ≤ 90 mmHg / Mean arterial pressure (MAP) ≤ 65mmhg or patient with Systolic BP > 90 mmHg / MAP >65mmHg on vasopressor.

Exclusion Criteria

  1. Patient likely to be in shock due to reason other than sepsis (e.g. cardiogenic or hemorrhagic shock)
  2. Decision taken for not intubating / ventilating /aggressive resuscitation prior to ICU admission
  3. Patient transferred from another ICU OR another hospital (only if stay >7 days)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143035


Contacts
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Contact: Sheila N Myatra, MD 9820156070 sheila150@hotmail.com
Contact: Nirmalyo N Lodh, DM 07984280078 nirmalyo1991@gmail.com

Locations
Show Show 248 study locations
Sponsors and Collaborators
Tata Memorial Centre
Indian Society of Critical Care Medicine
Investigators
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Principal Investigator: Sheila N Myatra, MD Tata Memorial Hospital, Parel, Mumbai-12
  Study Documents (Full-Text)

Documents provided by Sheila Nainan Myatra, Tata Memorial Centre:
Informed Consent Form  [PDF] July 19, 2019

Additional Information:
Publications:
Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. Erratum in: Crit Care Med. 2008 Apr;36(4):1394-6.
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

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Responsible Party: Sheila Nainan Myatra, Professor, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT04143035    
Other Study ID Numbers: 3364
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock