Sepsis in ICU:Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital

Sepsis Clinical Trial

Official title:

Sepsis in Intensive Care Unit :Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04015752
• Other study ID #: Sepsis in ICU.
• Status: Not yet recruiting
• Start date: August 2019
• Est. completion date: October 2020

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: Hanan Mahmoud, professor
• Phone: 01065735355
• Email: drhanan_abuelrus[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Clarify different causes of sepsis in patients admitted to ICU . as well asCompare causes and outcomes of sepsis between diabetics versus non diabetics .

3.Screening for the commonest organism causing sepsis in critically ill patients.

Determine better protocol therapy that help in decreasing mortality and morbidity in patients with sepsis in ICU.

Description:

Sepsis is a physiologic, pathologic, and biochemical abnormalities induced by infection.

sepsis is considered as a leading cause of mortality and critical illness worldwide by many conservative estimates.

sepsis epidemiology studies worldwide revealed a highly variable incidence of 13-300 per 100,000 inhabitants per year for severe sepsis and 11 per 100,000 inhabitants per year for septic shock .

factors such as advancing age, immunosuppression and multi-drug-resistant infection play a role in increasing incidence of sepsis during recent decades .

patients who survive sepsis often have long-term physical, psychological, and cognitive disabilities with significant health and social implications.

Patients with diabetes mellitus have an increased risk of developing infections and sepsis and they constitute 20.1-22.7% of all sepsis patients.

Infection also remains an important cause of death in diabetics. The prevalence of diabetes mellitus in Intensive Care Unit patients is as high as 30%, And such patients are at increased risk of experiencing in-hospital Complications, compared to patients without diabetes.

Infective complications may be reduced with lower blood glucose concentrations Moreover, in critically ill patients without diabetes, Hyperglycemia is associated with increased mortality, risk of infection, Kidney injury and cardiovascular complications.

Moreover, diabetes is a major risk factor for both Acute Kidney Injury and sepsis.

Sepsis also is a major cause of Acute Kidney Injury, which develops in one-fourth of all patients with sepsis and half of patients with bacteremia or shock .

Sepsis-related Acute Kidney Injury is associated with high mortality rates of up to 70%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

patients admitted to ICU for any reason and devoloped sepsis either on admission or later during thier hospital stay. patients having Criteria of sepsis or septic shock as defined by 3rd consensus guidelines (sepsis 3) ,2016

Exclusion Criteria:

Previous history of pulmonary problem . Previous history of cardiac disease. Previous history of Autoimmune disease immunocompromised patients

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock, Septic
• Toxemia

Intervention

Diagnostic Test:
• culture from infected site
ESR ,CRP,CBC, Renal and Liver function will be done on admission and follow up Culture: On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (14)

Bertoni AG, Saydah S, Brancati FL. Diabetes and the risk of infection-related mortality in the U.S. Diabetes Care. 2001 Jun;24(6):1044-9. — View Citation

de Boer IH, Rue TC, Hall YN, Heagerty PJ, Weiss NS, Himmelfarb J. Temporal trends in the prevalence of diabetic kidney disease in the United States. JAMA. 2011 Jun 22;305(24):2532-9. doi: 10.1001/jama.2011.861. — View Citation

Donati A, Damiani E, Domizi R, Botticelli L, Castagnani R, Gabbanelli V, Nataloni S, Carsetti A, Scorcella C, Adrario E, Pelaia P, Preiser JC. Glycaemic variability, infections and mortality in a medical-surgical intensive care unit. Crit Care Resusc. 2014 Mar;16(1):13-23. — View Citation

Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC. — View Citation

Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553. — View Citation

Jawad I, Lukšic I, Rafnsson SB. Assessing available information on the burden of sepsis: global estimates of incidence, prevalence and mortality. J Glob Health. 2012 Jun;2(1):010404. doi: 10.7189/jogh.02.010404. — View Citation

Koh GC, Peacock SJ, van der Poll T, Wiersinga WJ. The impact of diabetes on the pathogenesis of sepsis. Eur J Clin Microbiol Infect Dis. 2012 Apr;31(4):379-88. doi: 10.1007/s10096-011-1337-4. Epub 2011 Jul 30. Review. — View Citation

Luethi N, Cioccari L, Eastwood G, Biesenbach P, Morgan R, Sprogis S, Young H, Peck L, Knee Chong C, Moore S, Moon K, Ekinci EI, Deane AM, Bellomo R, Mårtensson J. Hospital-acquired complications in intensive care unit patients with diabetes: A before-and-after study of a conventional versus liberal glucose control protocol. Acta Anaesthesiol Scand. 2019 Jul;63(6):761-768. doi: 10.1111/aas.13354. Epub 2019 Mar 18. — View Citation

SepNet Critical Care Trials Group. Incidence of severe sepsis and septic shock in German intensive care units: the prospective, multicentre INSEP study. Intensive Care Med. 2016 Dec;42(12):1980-1989. doi: 10.1007/s00134-016-4504-3. Epub 2016 Sep 29. Erratum in: Intensive Care Med. 2017 Dec 1;:. — View Citation

Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289. Review. — View Citation

Stegenga ME, Vincent JL, Vail GM, Xie J, Haney DJ, Williams MD, Bernard GR, van der Poll T. Diabetes does not alter mortality or hemostatic and inflammatory responses in patients with severe sepsis. Crit Care Med. 2010 Feb;38(2):539-45. doi: 10.1097/CCM.0b013e3181c02726. — View Citation

Umpierrez G, Cardona S, Pasquel F, Jacobs S, Peng L, Unigwe M, Newton CA, Smiley-Byrd D, Vellanki P, Halkos M, Puskas JD, Guyton RA, Thourani VH. Randomized Controlled Trial of Intensive Versus Conservative Glucose Control in Patients Undergoing Coronary Artery Bypass Graft Surgery: GLUCO-CABG Trial. Diabetes Care. 2015 Sep;38(9):1665-72. doi: 10.2337/dc15-0303. Epub 2015 Jul 15. — View Citation

Venot M, Weis L, Clec'h C, Darmon M, Allaouchiche B, Goldgran-Tolédano D, Garrouste-Orgeas M, Adrie C, Timsit JF, Azoulay E. Acute Kidney Injury in Severe Sepsis and Septic Shock in Patients with and without Diabetes Mellitus: A Multicenter Study. PLoS One. 2015 May 28;10(5):e0127411. doi: 10.1371/journal.pone.0127411. eCollection 2015. — View Citation

Vincent JL, Marshall JC, Namendys-Silva SA, François B, Martin-Loeches I, Lipman J, Reinhart K, Antonelli M, Pickkers P, Njimi H, Jimenez E, Sakr Y; ICON investigators. Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit. Lancet Respir Med. 2014 May;2(5):380-6. doi: 10.1016/S2213-2600(14)70061-X. Epub 2014 Apr 14. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detect the most common organism causing sepsis in ICU .	applying culture and sensitivity tests for patients developed sepsis on admission and follow up will direct us to the proper treatment protocol for all patients.	20 days
Secondary	incidence of sepsis in diabetics versus non diabetics in ICU.	Asses the effect of hyperglycemia on sepsis outcomes.	15 days