Effect of Metformin Use on Mortality in Diabetic and Non Diabetic Patients With Sepsis and Septic Shock.

NCT05572060 | Unknown

• 1 other identifier: Metformin use in sepsis
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

We aimed to determine if metformin use in both diabetic and non diabetic patients with sepsis and septic shock affects 28 day mortality and its effect on inflammatory markers. Plasma rennin, serum lactate concentration and IL6 will be measured for predicting 28 days in-hospital mortality in patients with sepsis.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 28 day Mortality.

  death within 28 day of sepsis and septic shock where the occurrence of sepsis is hour 0 day 0.

  28 day.

Secondary Outcomes (3)

• Plasma rennin concentration (pg/ml) will be measured on admission and at one week.

  On admission and at 1 week after admission.

• IL6 concentration (ng/ml) will be measured on admission and at one week.

  On admission and at 1 week after admission.

• Serum lactate concentration (mmol/L) will be measured on admission and at one week.

  On admission and at 1 week after admission.

Study Arms (3)

Group C: (n=25) control.

ACTIVE COMPARATOR

patients will receive standardized protocol without receiving metformin.

Other: standardized protocol

Group D: (n=25) diabetic patients.

ACTIVE COMPARATOR

diabetic patients will receive standardized protocol and receiving metformin 500 mg every 8 hours since admission regardless of their random blood sugar with measurement of random blood sugar every hour and dextrose 25% infusion will be used if needed and also insulin infusion will be used when appropriate with target random blood sugar 140-180 in diabetic patients.

Drug: Metformin; Other: standardized protocol

Group ND: (n=25) non-diabetic patients.

ACTIVE COMPARATOR

patients will receive standardized protocol and receiving metformin 500 mg every 8 hours since admission regardless of their random blood sugar with measurement of random blood sugar every hour and dextrose 25% infusion will be used if needed and also insulin infusion will be used when appropriate with target random blood sugar 100-140 in non diabetic patients.

Drug: Metformin; Other: standardized protocol

Interventions

Metformin DRUG

Patient screening will be done using SOFA scoring and NEWS Supplemental oxygen will be supplied. Intubation and mechanical ventilation may be required Venous access will be established.CBC, chemistries, liver function tests,coagulation studies ,Peripheral blood cultures, urinalysis, microbiological cultures from suspected sources (eg, sputum, urine,etc),(ABG) and serum lactate will be obtained Crystalloids will be given at 30 mL/kg, started by one hour and completed within three hours Empiric antibiotic therapy is targeted at the suspected organism(s) In patients with lactic acidosis and severe acidemia, Sodium bicarbonate will be used to maintain the arterial pH above 7.15 In patients having persistent hypoperfusion vasopressors will be added Evaluation of volume status will be done using straight leg raising test and ultrasound guided IVC collapsibility index Plasma rennin, serum lactate and IL6 concentrations will be measured on admission and at one week.

Group D: (n=25) diabetic patients.; Group ND: (n=25) non-diabetic patients.

standardized protocol OTHER

standardized protocol

Group C: (n=25) control.; Group D: (n=25) diabetic patients.; Group ND: (n=25) non-diabetic patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both sexes aged ≥18 years old complaining of sepsis or septic shock with anticipated stay \>24 hours, and signed informed consent by patient or next-of-kin.

You may not qualify if:

• Age less than 18 years old, chronic kidney disease stage IV/V (baseline eGFR \<30ml/min/1.73m2), patients with acute coronary syndrome, or do not resuscitate order. Patients could be enrolled at any point during their admission.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.

  PMID: 1303622 BACKGROUND

• Deutschman CS, Tracey KJ. Sepsis: current dogma and new perspectives. Immunity. 2014 Apr 17;40(4):463-75. doi: 10.1016/j.immuni.2014.04.001.

  PMID: 24745331 BACKGROUND

• Sehgal M, Ladd HJ, Totapally B. Trends in Epidemiology and Microbiology of Severe Sepsis and Septic Shock in Children. Hosp Pediatr. 2020 Dec;10(12):1021-1030. doi: 10.1542/hpeds.2020-0174.

  PMID: 33208389 BACKGROUND

• Annane D, Bellissant E, Bollaert PE, Briegel J, Keh D, Kupfer Y, Pirracchio R, Rochwerg B. Corticosteroids for treating sepsis in children and adults. Cochrane Database Syst Rev. 2019 Dec 6;12(12):CD002243. doi: 10.1002/14651858.CD002243.pub4.

  PMID: 31808551 BACKGROUND

• Giusti L, Tesi M, Ciregia F, Marselli L, Zallocco L, Suleiman M, De Luca C, Del Guerra S, Zuccarini M, Trerotola M, Eizirik DL, Cnop M, Mazzoni MR, Marchetti P, Lucacchini A, Ronci M. The Protective Action of Metformin against Pro-Inflammatory Cytokine-Induced Human Islet Cell Damage and the Mechanisms Involved. Cells. 2022 Aug 8;11(15):2465. doi: 10.3390/cells11152465.

  PMID: 35954309 BACKGROUND

• Raith EP, Udy AA, Bailey M, McGloughlin S, MacIsaac C, Bellomo R, Pilcher DV; Australian and New Zealand Intensive Care Society (ANZICS) Centre for Outcomes and Resource Evaluation (CORE). Prognostic Accuracy of the SOFA Score, SIRS Criteria, and qSOFA Score for In-Hospital Mortality Among Adults With Suspected Infection Admitted to the Intensive Care Unit. JAMA. 2017 Jan 17;317(3):290-300. doi: 10.1001/jama.2016.20328.

  PMID: 28114553 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Osama Khaled Ahmed Abodeef, resident

  Assiut University

  STUDY CHAIR

• Abualauon Mohamed Abedalmohsen, MD

  Assiut University

  STUDY DIRECTOR

• Nagwa Mostafa Ibrahim, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama Khaled Ahmed Abodeef, resident

CONTACT

+201018089621; Miniosama_2010@yahoo.com

Abualauon Mohamed Abedalmohsen, MD

CONTACT

+201020170603; abualauon77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiology and ICU resident

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 7, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: October 7, 2022

Record last verified: 2022-10