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

• ClinicalTrials.gov Identifier: NCT04015752
• Recruitment Status: Unknown
• First Posted: July 11, 2019
• Last Update Posted: July 12, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Shaimaa Srour, Assiut University

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Sepsis; Septic Shock	Diagnostic Test: culture from infected site

Detailed 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%.

Study Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Sepsis in Intensive Care Unit :Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital
• Estimated Study Start Date: August 2019
• Estimated Primary Completion Date: July 2020
• Estimated Study Completion Date: October 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
diabetics; Full history with special attention to: Causes of admission to ICU . Duration of DM when present, medication used, controlled or not.; Complete physical examination with special attention to : Vital signs ( MAP, pulse, temp, RR). Signs of shock (cold clammy skin , oliguria, altered mental status ) Consciousness level. Source of infection (chest , abdomen ,catheter, JV canula,..).; Laboratory investigations includes : CBC , Liver and kidney functions → baseline and follow up. Arterial Blood Gases (ABG). Lactic acid level. HBA1C. ESR, CRP →baseline 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.	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.; Other Names: HbA1C; Arterial Blood Gases; Lactic acid level; CBC; ESR; CRP; liver and kidney function tests
non diabetics; Full history with special attention to: Causes of admission to ICU . Duration of DM when present medication used, controlled or not.; Complete physical examination with special attention to : Vital signs ( MAP, pulse, temp, RR) Signs of shock (cold clammy skin , oliguria, altered mental status ) Consciousness level. Source of infection (chest , abdomen ,catheter, JV canula,..).; Laboratory investigations CBC , Liver and kidney functions → baseline and follow up HBA1C. ESR, CRP →baseline 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.	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.; Other Names: HbA1C; Arterial Blood Gases; Lactic acid level; CBC; ESR; CRP; liver and kidney function tests
patients devoloped hyperglycemia in ICU only; Full history with special attention to: Causes of admission to ICU . Duration of DM when present medication used, controlled or not. 2. Complete physical examination with special attention to : Vital signs ( MAP, pulse, temp, RR) Signs of shock (cold clammy skin , oliguria, altered mental status ) Consciousness level. Source of infection (chest , abdomen ,catheter, CVP,..). 3. Laboratory investigations CBC , Liver and kidney functions → baseline and follow up HBA1C. ESR, CRP →baseline 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.	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.; Other Names: HbA1C; Arterial Blood Gases; Lactic acid level; CBC; ESR; CRP; liver and kidney function tests

Outcome Measures

Primary Outcome Measures :

1. detect the most common organism causing sepsis in ICU . [ Time Frame: 20 days ]
   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.

Secondary Outcome Measures :

1. incidence of sepsis in diabetics versus non diabetics in ICU. [ Time Frame: 15 days ]
   Asses the effect of hyperglycemia on sepsis outcomes.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

All patients admitted to ICU and devoloped sepsis or septic shock (even on admission or later-on ) as defined by 3rd consensus guidelines (sepsis 3) ,2016 patients then devided into 3 groups : Group 1: patients with Diabetes Mellitus (type 1or type 2). Group 2: patients with in-hospital hyperglycemia(not known to be diabetic). Group 3 : Normglycemic patients (without past or present history of DM ).

Criteria

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

Contacts and Locations

Contacts

Contact: Hanan Mahmoud, professor; 01065735355; drhanan_abuelrus@yahoo.com

Contact: Suhair kassim, PHD; 01069347314; Soher.kasem@yahoo.com

Sponsors and Collaborators

Assiut University

More Information

Publications:

Vincent JL, Marshall JC, Namendys-Silva SA, Francois 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.

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.

Jawad I, Luksic 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.

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;:

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.

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.

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.

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. doi: 10.2337/diacare.24.6.1044.

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, Martensson 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.

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.

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.

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.

Venot M, Weis L, Clec'h C, Darmon M, Allaouchiche B, Goldgran-Toledano 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.

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.

• Responsible Party: Shaimaa Srour, Principle Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04015752
• Other Study ID Numbers: Sepsis in ICU.
• First Posted: July 11, 2019
• Last Update Posted: July 12, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sepsis; Toxemia; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes