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OpenTrials
Completed

NCT Number: NCT03452865

Esomeprazole to Reduce Organ Failure in Sepsis

Sepsis is a severe disease with a high mortality rate and lack of efficacious therapies. Proton pump inhibitors (PPI) are drugs widely used to inhibit acid secretion by gastric cells and with a high safety profile. Carta and Rubartelli (IRCCS San Martino - Genova) have recently reported that PPI, such as esomeprazole, inhibit TNF-alfa and IL-1ß secretion. Moreover, they showed that a single administration of PPI protects mice from endotoxic shock with no adverse effects. PPI-SEPSIS is a randomized, double blind, controlled against placebo clinical trial to test if high-doses esomeprazole in septic patients reduces the severity of organs failure.

In parallel, the investigators will evaluate ex vivo in monocytes from septic patients: redox state and response to inflammatory stimuli; ATP release; metabolic changes and pH; cytokine production; the effects of PPI on these parameters.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Policlinico Univeristario Campus Bio-Medico, Rome, Lazio, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Admitted to intensive care unit or emergency department
  • Sepsis or septic shock
  • Able to express informed consent. For unconscious patients, current laws will be applied as requested by Ethical Committee.

Exclusion criteria

  • Able to express informed consent and deny it
  • Known allergy or intolerance to study drug
  • Little chance of survival, as defined by a SAPS II score more than 65 point
  • Concomitant acquired immunodeficiency syndrome
  • On immunosuppressant or long-term corticosteroid therapy
  • Receiving lifesaving drugs known to have a strong interference with esomeprazole
  • Sepsis or septic shock since over 36 hours
  • Severe hepatic dysfunction
  • Pregnant or breastfeeding

Treatment and study plan

Esomeprazole

Drug

160 mg of esomeprazole will be diluted in 100 ml of 0.9% sodium chloride for intravenous use for bolus.

For continuous intravenous infusion, 40 mg of esomeprazole will be reconstituted by adding 5 ml of 0.9% sodium chloride for intravenous use at a concentration of 8 mg/ml.

Placebo

Drug

0.9% sodium chloride (same ml of the study drug)

Primary outcomes

  1. SOFA score reduction

    Time frame: Days 1-28

    SOFA (sequential organ failure assessment) score is used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (better outcome) to 24 points (worse outcome).

Secondary outcomes

  1. Mortality

    Time frame: Day 28, 60 and 90

  2. Antibiotic-free days

    Time frame: Day 28

  3. Adjusted ICU-free days

    Time frame: Day 28

  4. Single organ failure severity

    Time frame: Days 1-28

    Highest mean difference in each different category of SOFA score. SOFA (sequential organ failure assessment) score is used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems which are added up. Each score ranges from 0 to 4. SOFA score ranges from 0 (better outcome) to 24 points (worse outcome).

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Collaborators

  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Registry information

Official study title

Proton Pump Inhibitors (PPI) as a New Strategy for Therapy in Sepsis: Clinical Trial to Reduce Severity of Organ Failure and in Vitro Experiments to Search Specific Hallmarks in Monocytes From Septic Patients and to Characterize the Mechanism of Action of PPI

Acronym: PPI-SEPSIS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2018
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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