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Clinical Evaluation of the Effect of Metformin in Sepsis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05979038
Recruitment Status : Recruiting
First Posted : August 7, 2023
Last Update Posted : September 13, 2023
Information provided by (Responsible Party):
Mai Tarek Ghannoum, German University in Cairo

Brief Summary:

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. It is considered a condition that arises when the body's response to an infection injures its own tissues and organs. The pathogenesis of sepsis is very complicated as it involves imbalance in inflammatory response, immune dysfunction, mitochondrial damage, coagulopathy, neuroendocrine immune network abnormalities, endoplasmic reticulum stress, autophagy, and other pathophysiological processes, and leads to organ dysfunction. Inflammatory Imbalance represents the most critical basis of sepsis pathogenesis. Sepsis is associated with many biochemical abnormalities that is correlated with patients' prognosis and risk of mortality including increased levels of lactate, procalcitonin and inflammatory cytokines as TNF alpha.

Metformin is an oral anti-diabetic drug from the class of biguanides. It is the first line treatment of diabetes type 2. It is widely used as it has good safety profile, low side effect and cheap cost. Metformin has been reported to have an anti-inflammatory and anti-microbial effect.

Some studies have shown that metformin has a beneficial effect in sepsis patients. Our study will be the first prospective controlled randomized trial to assess the clinical outcome of metformin in patients with sepsis.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Metformin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Metformin on the Clinical Outcome of ICU Patients With Sepsis
Actual Study Start Date : September 10, 2023
Estimated Primary Completion Date : June 15, 2024
Estimated Study Completion Date : July 10, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Metformin arm
In this arm patients will administrate metformin 500 mg three times a day together with the standard care of sepsis.
Drug: Metformin
Patients in the intervention arm will take metformin 500mg three times a day
Other Name: Glucophage

No Intervention: Control Arm
In this arm patients will receive the standard care of sepsis only

Primary Outcome Measures :
  1. 28 days mortality [ Time Frame: 28 days ]
    Patients mortality rate and time from ICU admission till death due to any cause will be assessed within 28 days even after discharge from the ICU.

Secondary Outcome Measures :
  1. 2.Total ICU lengths of stay: [ Time Frame: 28 days ]
    The number of days that the patient will stay in the ICU will be calculated.

  2. 3.Arterial blood gases (ABG): [ Time Frame: 28 days ]
    ABG will be measured daily for every patient throughout his/her stay in the ICU. The total number of days that ABG are abnormal will be calculated for every patients in order to get the number of abnormal readings and check after how long ABG returned to normal

  3. 4- Serum TNF alpha: [ Time Frame: 28 days ]
    Blood samples will be withdrawn at baseline and day ten of ICU admission from every patient included in the study to measure TNF alpha. Samples will be stored in -80C and will be assessed using ELISA technique.

  4. 5- Total Leucocytic Count (TLC): [ Time Frame: 28 days ]
    Blood samples will be withdrawn daily from every patient included in the study to measure TLC. The total number of days that TLC is high will be calculated for every patients in order to get the number of abnormal readings and check after how long TLC returned to normal ( 4000 to 11,000/microliters).

  5. 6- Sequential organ Failure assessment Scores (SOFA): [ Time Frame: 28 days ]
    SOFA score will be calculated daily for every patient to assess organ failure and recovery. Sequential Organ Failure Assessment score (SOFA) is a scoring system used to evaluate organ failure. The score is based on six different scores: respiratory, cardiovascular, hepatic, coagulation, renal and neurological system. It calculates the degree of organ failure by assigning a point of 0 (normal) to 4 (failure) for each organ. Score ranges from 0 (best) to 24 (worst) points. For calculating SOFA score the below table 1 will be used:(Singer et al., 2016a)

  6. 7- APACHE II Score: [ Time Frame: 28 days ]
    APACH II score will be calculated daily for every patient to assess disease severity. The score can help in the assessment of patients to determine the level & degree of diagnostic & therapeutic intervention. Score ranges from minimum 0 and maximum 71; increasing score is associated with an increasing risk of hospital death. For calculating APACHE score, below table will be used (Akavipat, 2019)

  7. 8-GCS Score: [ Time Frame: 28 days ]
    Glasgow Coma scale (GCS) will be calculated daily to assess patient's consciousness. It is scored between 3 and 15, with 3 being the worst and 15 the best. It is composed of 3 parameters: best eye response (E), best verbal response (V), and best motor response (M). A score of 13 or higher correlates with mild brain injury, a score of 9 to 12 correlates with moderate injury, and a score of 8 or less represents severe brain injury (Teasdale and Jennett, 1974).

  8. 9-28 days Readmission: [ Time Frame: 28 days ]
    The number of patients who were discharged from the ICU and returned again within 28 days will be calculated

  9. 10-Blood Pressure [ Time Frame: 28 days ]
    All patients included in the study will be monitored 24 hours a day (24/24) by putting them on a vital signs monitor in order to follow up their blood pressure. The total number of abnormal blood pressure measurements will be calculated for every patient. Mean arterial blood pressure will also be calculated (target is 65 mm Hg) and the total number of days patient will need a vasopressor will be calculated and doses of vasopressor will be documented.

  10. 11-Mechanical Ventilation: [ Time Frame: 28 days ]
    Number of patients who will need mechanical ventilation will be calculated. In addition, ventilation free days will be assessed for every patient.

  11. 12-Serum Lactate levels: [ Time Frame: 28 days ]
    Blood samples will be withdrawn every other day from every patient included in the study to measure serum lactate levels. The lactate cutoffs determining an elevated level ranged from 1.6-2.5 mmol/L (Evans et al., 2021). Patients with elevated serum lactate levels will be closely monitored. The number of days that serum lactate levels are high will be calculated for every patient throughout the study

  12. GIT Disturbances: [ Time Frame: 28 days ]
    Patient will be interviewed for the incidence of nausea, vomiting or diarrhea. If patient cannot reply (low conscious level), nurses will be asked. The total number of days that patient will suffer any of the GIT disturbances will be calculated and documented.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age more than 18 years old.
  • A diagnosis of sepsis according to the latest Sepsis-3 definition
  • Estimated GFR >45 ml/min

Exclusion Criteria:

  • • Immunosuppressed or end stage cancer.

    • Septic Shock.
    • Pregnancy and breast feeding.
    • Patients on metformin, Sodium glucose cotransporters or Gliptins.
    • End stage hepatic disease.
    • Contraindications to metformin (chronic respiratory failure, chronic cardiac failure, chronic kidney or liver disease, myocardial infarction within the last month).
    • Patients with hypersensitivity to metformin.

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 identifier (NCT number): NCT05979038

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Contact: Mai M.T Ghannoum, Assistant Lecturer 002-01221054807
Contact: Mohamed H. Solayman, Lecturer 002-01005882550

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Al Demerdash University Hospital Recruiting
Cairo, Egypt
Contact: Mai M.T Ghannoum, Ass. Lecturer    01221054807 ext 002   
Contact: Mai Shawki, Ass. Prof    01001701461 ext 002   
Sponsors and Collaborators
German University in Cairo
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Responsible Party: Mai Tarek Ghannoum, Assistant Lecturer of Clinical Pharmacy, German University in Cairo Identifier: NCT05979038    
Other Study ID Numbers: FMASU MD146/2023
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Systemic Inflammatory Response Syndrome
Pathologic Processes
Hypoglycemic Agents
Physiological Effects of Drugs