SepsisNCT04015752
Sepsis in ICU:Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital
An observational study of Sepsis and Septic Shock, run by Assiut University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- culture from infected site
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 ).
Who may be able to join
- 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
Who cannot join
- Previous history of pulmonary problem . Previous history of cardiac disease. Previous history of Autoimmune disease immunocompromised patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sepsis in Intensive Care Unit :Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital
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.
Read the 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%.
- Conditions
- Sepsis, Septic Shock
- Being tested
- culture from infected site
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culture from infected siteDiagnostic test
Also called HbA1C, Arterial Blood Gases, Lactic acid level, CBC
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.
| Study group | Role | What they receive |
|---|---|---|
| diabetics | 1. 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, JV canula,..).
3. 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. Receives: Diagnostic Test: culture from infected site | |
| non diabetics | 1. 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, JV canula,..).
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. Receives: Diagnostic Test: culture from infected site | |
| 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. Receives: Diagnostic Test: culture from infected site |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 days
Secondary outcomes (1)
incidence of sepsis in diabetics versus non diabetics in ICU.
Asses the effect of hyperglycemia on sepsis outcomes.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Srour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015752
- Sponsor's protocol ID
- Sepsis in ICU.
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 24740011Fleischmann 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.
PubMed 26414292Jawad 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.
PubMed 23198133SepNet 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.
PubMed 27686355Iwashyna 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.
PubMed 20978258Stegenga 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.
PubMed 19851093Koh 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.
PubMed 21805196Bertoni 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.
PubMed 11375368Luethi 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.
PubMed 30882892Donati 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.
PubMed 24588431Umpierrez 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.
PubMed 26180108de 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.
PubMed 21693741Venot 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.
PubMed 26020231Shankar-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.
PubMed 26903336
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis in Intensive Care Unit :Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT04015752
- Acronym / sponsor ID
- Sepsis in ICU.
- Conditions
- Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diabetics | – | Diagnostic Test: culture from infected site1. 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, JV canula,..). 3. 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. |
| non diabetics | – | Diagnostic Test: culture from infected site1. 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, JV canula,..). 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. |
| patients devoloped hyperglycemia in ICU only | – | Diagnostic Test: culture from infected siteFull 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 ).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Previous history of pulmonary problem . Previous history of cardiac disease. Previous history of Autoimmune disease immunocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| culture from infected siteAlso: HbA1C, Arterial Blood Gases, Lactic acid level, CBCESR ,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. | Diagnostic test | diabetics, non diabetics, patients devoloped hyperglycemia in ICU only |
Primary outcome
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.
1 secondary outcome
incidence of sepsis in diabetics versus non diabetics in ICU.
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Background: PubMed 24740011Vincent 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.
- Background: PubMed 26414292Fleischmann 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.
- Background: PubMed 23198133Jawad 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.
- Background: PubMed 27686355SepNet 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.
- Background: PubMed 20978258Iwashyna 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.
- Background: PubMed 19851093Stegenga 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.
- Background: PubMed 21805196Koh 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.
- Background: PubMed 11375368Bertoni 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.
- Background: PubMed 30882892Luethi 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.
- Background: PubMed 24588431Donati 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.
- Background: PubMed 26180108Umpierrez 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.
- Background: PubMed 21693741de 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan Mahmoud, professor (01065735355, drhanan_abuelrus@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect the most common organism causing sepsis in ICU . (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04015752, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.