Ventilator Associated EventNCT05556694
Cumulative Fluids Balance and Ventilator Associated Events
An observational study of Ventilator Associated Event, run by Damanhour University at 1 site in Egypt.
Trial summary
Fluid therapy is widely used to improve organ perfusion and survival in critically patients. Fluid therapy is an important component of intensive care management; however, optimal fluid management is unknown. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventilator Associated Event
- What is being tested?
- calculation of cumulative fluid balance
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Oct 2022to 18 May 2023
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: critically ill patients
Who may be able to join
- aged ≥18 years,
- mechanically ventilated for ≥48 h and remain in the intensive care ≥4 days.
Who cannot join
- Patients with acute renal failure and needs dialysis,
- increasing daily minimum positive end-expiratory pressure (PEEP) or Fio2 during MV treatment
- hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Cumulative Fluids Balance and Ventilator Associated Events in Critically Ill Patients: a Prospective Cohort Study
Fluid therapy is widely used to improve organ perfusion and survival in critically patients. Fluid therapy is an important component of intensive care management; however, optimal fluid management is unknown. Inadequate or excessive fluid resuscitation, on the other hand, is linked with a poor prognosis; the former can cause tissue hypo-perfusion and exacerbate organ dysfunction, while the latter can raise the risk of heart failure, pulmonary edema, and pleural effusions. Ventilator-associated lung injury (VALI) is a devastating complication of assisted mechanical ventilation (MV) and is one of the root causes of prolonged MV.
Read the detailed description
This study is designed to test the association between cumulative fluids balance and ventilator associated events among critically ill patients.
Setting: This research will be carried out in four General Intensive Care Units at two hospitals in El Beheira Governorate, Egypt.
- For three months, from October 1, 2022 to January, 2023, all newly admitted mechanically ventilated patients who will fulfill the inclusion criteria and agree to participate will be screened on a daily basis.
- The investigators will calculate cumulative fluid balance as daily fluid balance within four days of the event of interest. Cumulative fluid balance will be computed as the sum of daily fluid balances over the previous 24 hours, calculated by total fluid input minus total fluid output on a specific day of ICU admission over the first four calendar days of mechanical ventilation. Insensible fluid loss, such as perspiration or evaporative water loss related to respiration will not be routinely assessed and will not be included in the calculation of cumulative fluid balance. The cumulative fluid balance from day 0 to day 1 will be labelled as day 1, and the following days as day 2 and day 3. Cumulative fluid balance at day 3 refers to the cumulative fluid balance during the first four calendar days.
- Variables associated with VAEs will be assessed for each patient including: age, gender, admission diagnosis, comorbidities; and ICU length of stay, APACH II score, Sofa score and duration of tracheal intubation.
- Conditions
- Ventilator Associated Event
- Being tested
- calculation of cumulative fluid balance
- Keywords
- Cumulative fluids balance, Ventilator Associated Event, Critically ill patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calculation of cumulative fluid balanceDiagnostic test
Also called VAEs assessment
- We will calculate cumulative fluid balance as daily fluid balance within four days of the event of interest. Cumulative fluid balance will be computed as the sum of daily fluid balances over the previous 24 hours, calculated by total fluid input minus total fluid output on a specific day of ICU admission over the first four calendar days of mechanical ventilation. Insensible fluid loss, such as perspiration or evaporative water loss related to respiration will not be routinely assessed and will not be included in the calculation of cumulative fluid balance. The cumulative fluid balance from day 0 to day 1 will be labelled as day 1, and the following days as day 2 and day 3. Cumulative fluid balance at day 3 refers to the cumulative fluid balance during the first four calendar days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-Associated Event
VAEs classified as ventilator-associated complication (VAC), infection-related ventilator-associated complication (IVAC), or the possible ventilator-associated pneumonia (PVAP).
Measured: 7 days of mechanical ventilation
Secondary outcomes (3)
Duration of MV
Duration of mechanical ventilation
Measured: 7days
ICU length of stay
ICU length of stay
Measured: participants will be followed for the ICU length of stay, an expected average of 4 weeks
ICU mortality
ICU mortality
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start18 Oct 2022
- Primary completion18 Apr 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated EventStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Younes, Damanhour University
- Investigators
- Sahar Y Othman, Ass. Prof., Study chair, Faculty of Nursing, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556694
- Sponsor's protocol ID
- ventilator associated events
- Status last verified
- Aug 2023
- First submitted
- 17 Sep 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Unki P, Save S. Analysis of Fluid Balance as Predictor of Length of Assisted Mechanical Ventilation in Children Admitted to Pediatric Intensive Care Unit (PICU). Int J Pediatr. 2022 Mar 20;2022:2090323. doi: 10.1155/2022/2090323. eCollection 2022.
PubMed 35356099Wang W, Zhu S, He Q, Wang M, Kang Y, Zhang R, Ji P, Zou K, Klompas M, Zong Z, Sun X. Fluid Balance and Ventilator-Associated Events Among Patients Admitted to ICUs in China: A Nested Case-Control Study. Crit Care Med. 2022 Feb 1;50(2):307-316. doi: 10.1097/CCM.0000000000005227.
PubMed 34473657Chao WC, Chang WL, Wu CL, Chan MC. Using Objective Fluid Balance Data to Identify Pulmonary Edema in Subjects With Ventilator-Associated Events. Respir Care. 2018 Nov;63(11):1413-1420. doi: 10.4187/respcare.06221. Epub 2018 Aug 7.
PubMed 30087192Fang WF, Fang YT, Huang CH, Chen YM, Chang YC, Lin CY, Hung KY, Chang YT, Chen HC, Huang KT, Chang HC, Chen YC, Wang YH, Wang CC, Lin MC. Risk factors and associated outcomes of ventilator-associated events developed in 28 days among sepsis patients admitted to intensive care unit. Sci Rep. 2020 Jul 29;10(1):12702. doi: 10.1038/s41598-020-69731-3.
PubMed 32728165Klompas M, Branson R, Cawcutt K, Crist M, Eichenwald EC, Greene LR, Lee G, Maragakis LL, Powell K, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia, ventilator-associated events, and nonventilator hospital-acquired pneumonia in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2022 Jun;43(6):687-713. doi: 10.1017/ice.2022.88. Epub 2022 May 20.
PubMed 35589091
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cumulative Fluids Balance and Ventilator Associated Events in Critically Ill Patients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05556694
- Acronym / sponsor ID
- ventilator associated events
- Conditions
- Ventilator Associated Event
- Keywords
- Cumulative fluids balance, Ventilator Associated Event, Critically ill patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 27 Sep 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.
Fluid therapy is widely used to improve organ perfusion and survival in critically patients. Fluid therapy is an important component of intensive care management; however, optimal fluid management is unknown. Inadequate or excessive fluid resuscitation, on the other hand, is linked with a poor prognosis; the former can cause tissue hypo-perfusion and exacerbate organ dysfunction, while the latter can raise the risk of heart failure, pulmonary edema, and pleural effusions. Ventilator-associated lung injury (VALI) is a devastating complication of assisted mechanical ventilation (MV) and is one of the root causes of prolonged MV.
Detailed description
This study is designed to test the association between cumulative fluids balance and ventilator associated events among critically ill patients.
Setting: This research will be carried out in four General Intensive Care Units at two hospitals in El Beheira Governorate, Egypt.
- For three months, from October 1, 2022 to January, 2023, all newly admitted mechanically ventilated patients who will fulfill the inclusion criteria and agree to participate will be screened on a daily basis.
- The investigators will calculate cumulative fluid balance as daily fluid balance within four days of the event of interest. Cumulative fluid balance will be computed as the sum of daily fluid balances over the previous 24 hours, calculated by total fluid input minus total fluid output on a specific day of ICU admission over the first four calendar days of mechanical ventilation. Insensible fluid loss, such as perspiration or evaporative water loss related to respiration will not be routinely assessed and will not be included in the calculation of cumulative fluid balance. The cumulative fluid balance from day 0 to day 1 will be labelled as day 1, and the following days as day 2 and day 3. Cumulative fluid balance at day 3 refers to the cumulative fluid balance during the first four calendar days.
- Variables associated with VAEs will be assessed for each patient including: age, gender, admission diagnosis, comorbidities; and ICU length of stay, APACH II score, Sofa score and duration of tracheal intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- critically ill patients
Key inclusion criteria (2 listed)
- aged ≥18 years,
- mechanically ventilated for ≥48 h and remain in the intensive care ≥4 days.
Key exclusion criteria (3 listed)
- Patients with acute renal failure and needs dialysis,
- increasing daily minimum positive end-expiratory pressure (PEEP) or Fio2 during MV treatment
- hemodynamic instability
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 |
|---|---|---|
| calculation of cumulative fluid balanceAlso: VAEs assessment- We will calculate cumulative fluid balance as daily fluid balance within four days of the event of interest. Cumulative fluid balance will be computed as the sum of daily fluid balances over the previous 24 hours, calculated by total fluid input minus total fluid output on a specific day of ICU admission over the first four calendar days of mechanical ventilation. Insensible fluid loss, such as perspiration or evaporative water loss related to respiration will not be routinely assessed and will not be included in the calculation of cumulative fluid balance. The cumulative fluid balance from day 0 to day 1 will be labelled as day 1, and the following days as day 2 and day 3. Cumulative fluid balance at day 3 refers to the cumulative fluid balance during the first four calendar days. | Diagnostic test | – |
Primary outcome
Ventilator-Associated Event
Time frame: 7 days of mechanical ventilation
VAEs classified as ventilator-associated complication (VAC), infection-related ventilator-associated complication (IVAC), or the possible ventilator-associated pneumonia (PVAP).
3 secondary outcomes
Duration of MV
Time frame: 7days
ICU length of stay
Time frame: participants will be followed for the ICU length of stay, an expected average of 4 weeks
ICU mortality
Time frame: 28 day
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 Aug 2023.
- Background: PubMed 35356099Unki P, Save S. Analysis of Fluid Balance as Predictor of Length of Assisted Mechanical Ventilation in Children Admitted to Pediatric Intensive Care Unit (PICU). Int J Pediatr. 2022 Mar 20;2022:2090323. doi: 10.1155/2022/2090323. eCollection 2022.
- Background: PubMed 34473657Wang W, Zhu S, He Q, Wang M, Kang Y, Zhang R, Ji P, Zou K, Klompas M, Zong Z, Sun X. Fluid Balance and Ventilator-Associated Events Among Patients Admitted to ICUs in China: A Nested Case-Control Study. Crit Care Med. 2022 Feb 1;50(2):307-316. doi: 10.1097/CCM.0000000000005227.
- Background: PubMed 30087192Chao WC, Chang WL, Wu CL, Chan MC. Using Objective Fluid Balance Data to Identify Pulmonary Edema in Subjects With Ventilator-Associated Events. Respir Care. 2018 Nov;63(11):1413-1420. doi: 10.4187/respcare.06221. Epub 2018 Aug 7.
- Background: PubMed 32728165Fang WF, Fang YT, Huang CH, Chen YM, Chang YC, Lin CY, Hung KY, Chang YT, Chen HC, Huang KT, Chang HC, Chen YC, Wang YH, Wang CC, Lin MC. Risk factors and associated outcomes of ventilator-associated events developed in 28 days among sepsis patients admitted to intensive care unit. Sci Rep. 2020 Jul 29;10(1):12702. doi: 10.1038/s41598-020-69731-3.
- Background: PubMed 35589091Klompas M, Branson R, Cawcutt K, Crist M, Eichenwald EC, Greene LR, Lee G, Maragakis LL, Powell K, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia, ventilator-associated events, and nonventilator hospital-acquired pneumonia in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2022 Jun;43(6):687-713. doi: 10.1017/ice.2022.88. Epub 2022 May 20.
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Ventilator-Associated Events
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.
Sahar Y Othman, Ass. Prof. study chair
Faculty of Nursing, Damanhour 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 Ventilator Associated Event, run by Damanhour 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 2 inclusion and 3 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 Aug 2023. 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?
Ventilator-Associated Event (time frame: 7 days of mechanical ventilation). 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 NCT05556694, which also lists 5 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 15 Aug 2023.