Aspiration; Mucus in Respiratory TractSepsisinRICUNCT05240157
Sepsis in Respiratory Intensive Care Unit
An observational study of Aspiration; Mucus in Respiratory Tract, run by Ain Shams University at 1 site in Egypt.
Trial summary
Sepsis is the most common cause of death in non coronary intensive care units (ICUs). In the past 2 decades, the world has witnessed significant increase in the occurrence rate of sepsis (1). In the ICU, sepsis maybe community acquired (already present on admission) or hospital acquired (obtained during ICU stay). Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Aspiration; Mucus in Respiratory Tract
- What is being tested?
- Corticosteroid Derivatives
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 30 Nov 2019
- How long will I take part?
- 7 Days
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted at Respiratory Intensive Care Unit (RICU) of Abbassia Chest Hospital, Cairo, Egypt, either with sepsis or acquired sepsis in the RICU
Who may be able to join
- Patients ≥ 18 years old with sepsis or septic shock either on admission or acquired at RICU and all episodes of sepsis for the same patient were counted.
Who cannot join
- Patients with length of stay (LOS) at RICU less than 24 hours, patients readmitted at RICU during the same hospitalization, patients admitted at RICU post cardiac arrest, or patients with malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Outcome of Sepsis in Respiratory Intensive Care Unit
Sepsis is the most common cause of death in non coronary intensive care units (ICUs). In the past 2 decades, the world has witnessed significant increase in the occurrence rate of sepsis (1).
In the ICU, sepsis maybe community acquired (already present on admission) or hospital acquired (obtained during ICU stay).
This study will add adequate data about incidence and outcome of sepsis in Respiratory Intensive Care Unit.
Read the detailed description
Objective: assessing the incidence and outcome of sepsis in Respiratory Intensive Care Unit, providing a crucially important data to increase awareness of the impact of sepsis and highlighting the need for continued research into potential preventive and therapeutic interventions.
Patients and Methods:
This prospective observational cohort study was conducted upon patients admitted at Respiratory Intensive Care Unit (RICU) of Abbassia Chest Hospital, Cairo, Egypt, either with sepsis or acquired sepsis in the RICU; from 1st of May 2019 to 30th of November 2019.
- Inclusion Criteria: Patients ≥ 18 years old with sepsis or septic shock either on admission or acquired at RICU and all episodes of sepsis for the same patient were counted.
- Exclusion Criteria: Patients with length of stay (LOS) at RICU less than 24 hours, patients readmitted at RICU during the same hospitalization, patients admitted at RICU post cardiac arrest, or patients with malignancies.
Data collection and recording:
On admission, the following was done and recorded for all participants:
- Detailed medical history; including history of previous ICU admission or mechanical ventilation, last antibiotic intake, infected intra venous (IV) or central venous (CV) lines, associated comorbidities and reason of ICU admission.
- Full general and local chest clinical examination.
- Need for vasoactive therapy, fluid balance and need for renal replacement therapy.
- Laboratory investigations:
- Complete blood picture (CBC).
- Arterial blood gases analysis (ABGs) on a daily basis.
- Serum Sodium (Na) and Potassium (K).
- Liver and Kidney function tests.
- Serum lactate (repeated when needed to fulfill criteria for diagnosis of septic shock).
- Radiological investigations;
- Chest X ray (CXR).
- Computed Tomography chest, or brain (when appropriate).
- Microbiological samples culture and sensitivity (when appropriate): Sputum, urine, pleural fluid, or from infected IV line according to the suspected site. Type of infection (community or hospital acquired), infection site: (lungs, urinary tract, abdomen, surgical wound), pathogenic organisms (gram positive, gram negative, atypical bacteria and fungi) were recorded.
- Scores:
- Quick Sequential Organ Failure Assessment (qSOFA) score was recorded at emergency room. (3)
- Sequential Organ Failure Assessment (SOFA) score was recorded upon RICU admission and on 3rd and 7th day of ICU stay. (4)
- Acute Physiology and Chronic Health Evaluation (APACHE II) score was recorded within 24 hours from patient RICU admission. (3,5)
- Recording of following points:
- Number of patients who were on mechanical ventilation, length of RICU stay, presence of comorbidities, survived patients and dead ones, as regards causes of death and risk factors.
- Complications e.g., acute respiratory distress syndrome (ARDS), acute kidney injury (AKI), septic shock.
Measured Outcomes:
- Primary: Incidence of sepsis, mortality from sepsis.
- Secondary: RICU length of stay due to sepsis, complications from sepsis, mechanical ventilation due to sepsis, need for vasoactive agents.
- Total RICU mortality was also recorded.
Management:
All patients were subjected to the following management protocol regarding the recent Surviving Sepsis Campaign Bundle Update (6):
- Measuring lactate level with serial measurement if it was more than 2 mmol/L.
- Blood culture prior to antibiotic administration.
- For patients with sepsis, early empiric broad-spectrum antibiotic therapy initiated antimicrobial coverage included either an extended spectrum beta lactam, a third or fourth generation cephalosporin, or a carbapenem. Additional consideration was paid to methicillin resistant Staphylococcus aureus (MRSA) risk factors and if present, empiric vancomycin administration was advised. Widespread use of combination therapy, the use of multiple antibiotics with different pharmacodynamic profiles and mechanisms of action reported a synergistic effect with the addition of an aminoglycoside to a beta- lactam Combination therapy has been shown to improve survival. Patients with a high risk of mortality such as septic shock received a combination therapy with at least two different classes of antibiotics depending on type of organism, source of infection, choice of antibiotics kept in mind the most organisms isolated from septic patients.
- Early fluid resuscitation using 30 mL/Kg crystalloid fluid was given for cases of hypotension or when lactate level > 4mmol/L.
- Perfusion assessment using CVP and central venues oxygen saturation.
- Vasopressor use (norepinephrine was given) for persistent hypotension to maintain MAP ≥ 65 mmHg.
- Adjunctive therapy with steroids (200 mg IV hydrocortisone/day) was given in patients with sepsis who remain hemodynamically unstable despite adequate fluid resuscitation and vasopressor therapy.
- Glycemic control was done when patient's blood glucose level exceeded 180 mg/dL by administrating insulin.
Study tools and definitions:
The sequential organ failure assessment (SOFA) score was used to demonstrate organ dysfunction (4). Sepsis was defined as having SOFA score of 2 or more plus evidence of infection. Septic shock was defined when persistent hypotension required the use of vasopressors to maintain a MAP ≥ 65 mmHg, and a serum lactate > 2 mmol/L that persisted despite adequate fluid resuscitation. (4) Infection was suspected and confirmed from history, examination, laboratory, radiological and microbiological investigations. ICU acquired infection was defined as infection identified at least 48 hours after ICU admission, while non-ICU acquired infection was defined as infection presented on admission or within the first 48 hours after ICU admission. (7) ARDS was defined according to Berlin definition (8). Acute kidney injury was defined as an abrupt (within hours) decrease in kidney function based on an acute decrease of glomerular filtration rate, as reflected by an acute rise in serum creatinine levels and/or a decline in urine output over a given time interval. (9)
Statistical Analysis:
Data were collected, revised, coded and entered to the Statistical Package for Social Science (IBM SPSS) version 23. The quantitative data were presented as mean, standard deviation, frequency (number of cases and percentage) and ranges when their distribution found parametric and median with interquartile range when their distribution found non-parametric. Qualitative variables were presented as number and percentages. Comparison of numerical variables between the study groups was done using student t- test and paired t-test. The comparison of categorical data was done by using Chi-square test. The level of significance was taken at p value ≤ 0.05 as follows: p > 0.05: non-significant, p < 0.05: significant and p < 0.01: highly significant.
- Conditions
- Aspiration; Mucus in Respiratory Tract
- Being tested
- Corticosteroid Derivatives
- Keywords
- Sepsis, SOFA score, Respiratory ICU
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid DerivativesDrug
Also called antibiotics
observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sepsis
Outcome of sepsis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 May 2019
- Primary completion30 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration; Mucus in Respiratory TractStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf A Elmaraghy, Ain Shams University
- Investigators
- Ashraf M Madkour, Prosessor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240157
- Sponsor's protocol ID
- FMASU MS282/2019
- Acronym
- SepsisinRICU
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of patients data
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Outcome of Sepsis in Respiratory Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05240157
- Acronym / sponsor ID
- SepsisinRICU / FMASU MS282/2019
- Conditions
- Aspiration; Mucus in Respiratory Tract
- Keywords
- Sepsis, SOFA score, Respiratory ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 15 Feb 2022 (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.
Sepsis is the most common cause of death in non coronary intensive care units (ICUs). In the past 2 decades, the world has witnessed significant increase in the occurrence rate of sepsis (1).
In the ICU, sepsis maybe community acquired (already present on admission) or hospital acquired (obtained during ICU stay).
This study will add adequate data about incidence and outcome of sepsis in Respiratory Intensive Care Unit.
Detailed description
Objective: assessing the incidence and outcome of sepsis in Respiratory Intensive Care Unit, providing a crucially important data to increase awareness of the impact of sepsis and highlighting the need for continued research into potential preventive and therapeutic interventions.
Patients and Methods:
This prospective observational cohort study was conducted upon patients admitted at Respiratory Intensive Care Unit (RICU) of Abbassia Chest Hospital, Cairo, Egypt, either with sepsis or acquired sepsis in the RICU; from 1st of May 2019 to 30th of November 2019.
- Inclusion Criteria: Patients ≥ 18 years old with sepsis or septic shock either on admission or acquired at RICU and all episodes of sepsis for the same patient were counted.
- Exclusion Criteria: Patients with length of stay (LOS) at RICU less than 24 hours, patients readmitted at RICU during the same hospitalization, patients admitted at RICU post cardiac arrest, or patients with malignancies.
Data collection and recording:
On admission, the following was done and recorded for all participants:
- Detailed medical history; including history of previous ICU admission or mechanical ventilation, last antibiotic intake, infected intra venous (IV) or central venous (CV) lines, associated comorbidities and reason of ICU admission.
- Full general and local chest clinical examination.
- Need for vasoactive therapy, fluid balance and need for renal replacement therapy.
- Laboratory investigations:
- Complete blood picture (CBC).
- Arterial blood gases analysis (ABGs) on a daily basis.
- Serum Sodium (Na) and Potassium (K).
- Liver and Kidney function tests.
- Serum lactate (repeated when needed to fulfill criteria for diagnosis of septic shock).
- Radiological investigations;
- Chest X ray (CXR).
- Computed Tomography chest, or brain (when appropriate).
- Microbiological samples culture and sensitivity (when appropriate): Sputum, urine, pleural fluid, or from infected IV line according to the suspected site. Type of infection (community or hospital acquired), infection site: (lungs, urinary tract, abdomen, surgical wound), pathogenic organisms (gram positive, gram negative, atypical bacteria and fungi) were recorded.
- Scores:
- Quick Sequential Organ Failure Assessment (qSOFA) score was recorded at emergency room. (3)
- Sequential Organ Failure Assessment (SOFA) score was recorded upon RICU admission and on 3rd and 7th day of ICU stay. (4)
- Acute Physiology and Chronic Health Evaluation (APACHE II) score was recorded within 24 hours from patient RICU admission. (3,5)
- Recording of following points:
- Number of patients who were on mechanical ventilation, length of RICU stay, presence of comorbidities, survived patients and dead ones, as regards causes of death and risk factors.
- Complications e.g., acute respiratory distress syndrome (ARDS), acute kidney injury (AKI), septic shock.
Measured Outcomes:
- Primary: Incidence of sepsis, mortality from sepsis.
- Secondary: RICU length of stay due to sepsis, complications from sepsis, mechanical ventilation due to sepsis, need for vasoactive agents.
- Total RICU mortality was also recorded.
Management:
All patients were subjected to the following management protocol regarding the recent Surviving Sepsis Campaign Bundle Update (6):
- Measuring lactate level with serial measurement if it was more than 2 mmol/L.
- Blood culture prior to antibiotic administration.
- For patients with sepsis, early empiric broad-spectrum antibiotic therapy initiated antimicrobial coverage included either an extended spectrum beta lactam, a third or fourth generation cephalosporin, or a carbapenem. Additional consideration was paid to methicillin resistant Staphylococcus aureus (MRSA) risk factors and if present, empiric vancomycin administration was advised. Widespread use of combination therapy, the use of multiple antibiotics with different pharmacodynamic profiles and mechanisms of action reported a synergistic effect with the addition of an aminoglycoside to a beta- lactam Combination therapy has been shown to improve survival. Patients with a high risk of mortality such as septic shock received a combination therapy with at least two different classes of antibiotics depending on type of organism, source of infection, choice of antibiotics kept in mind the most organisms isolated from septic patients.
- Early fluid resuscitation using 30 mL/Kg crystalloid fluid was given for cases of hypotension or when lactate level > 4mmol/L.
- Perfusion assessment using CVP and central venues oxygen saturation.
- Vasopressor use (norepinephrine was given) for persistent hypotension to maintain MAP ≥ 65 mmHg.
- Adjunctive therapy with steroids (200 mg IV hydrocortisone/day) was given in patients with sepsis who remain hemodynamically unstable despite adequate fluid resuscitation and vasopressor therapy.
- Glycemic control was done when patient's blood glucose level exceeded 180 mg/dL by administrating insulin.
Study tools and definitions:
The sequential organ failure assessment (SOFA) score was used to demonstrate organ dysfunction (4). Sepsis was defined as having SOFA score of 2 or more plus evidence of infection. Septic shock was defined when persistent hypotension required the use of vasopressors to maintain a MAP ≥ 65 mmHg, and a serum lactate > 2 mmol/L that persisted despite adequate fluid resuscitation. (4) Infection was suspected and confirmed from history, examination, laboratory, radiological and microbiological investigations. ICU acquired infection was defined as infection identified at least 48 hours after ICU admission, while non-ICU acquired infection was defined as infection presented on admission or within the first 48 hours after ICU admission. (7) ARDS was defined according to Berlin definition (8). Acute kidney injury was defined as an abrupt (within hours) decrease in kidney function based on an acute decrease of glomerular filtration rate, as reflected by an acute rise in serum creatinine levels and/or a decline in urine output over a given time interval. (9)
Statistical Analysis:
Data were collected, revised, coded and entered to the Statistical Package for Social Science (IBM SPSS) version 23. The quantitative data were presented as mean, standard deviation, frequency (number of cases and percentage) and ranges when their distribution found parametric and median with interquartile range when their distribution found non-parametric. Qualitative variables were presented as number and percentages. Comparison of numerical variables between the study groups was done using student t- test and paired t-test. The comparison of categorical data was done by using Chi-square test. The level of significance was taken at p value ≤ 0.05 as follows: p > 0.05: non-significant, p < 0.05: significant and p < 0.01: highly significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted at Respiratory Intensive Care Unit (RICU) of Abbassia Chest Hospital, Cairo, Egypt, either with sepsis or acquired sepsis in the RICU
Key inclusion criteria (1 listed)
- Patients ≥ 18 years old with sepsis or septic shock either on admission or acquired at RICU and all episodes of sepsis for the same patient were counted.
Key exclusion criteria (1 listed)
- Patients with length of stay (LOS) at RICU less than 24 hours, patients readmitted at RICU during the same hospitalization, patients admitted at RICU post cardiac arrest, or patients with malignancies
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 |
|---|---|---|
| Corticosteroid DerivativesAlso: antibioticsobservational | Drug | – |
Primary outcome
Incidence of sepsis
Time frame: 6 months
Outcome of sepsis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No. No sharing of patients data
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.
Ashraf M Madkour, Prosessor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration; Mucus in Respiratory Tract, run by Ain Shams University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sepsis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2022.