Cumulative Fluids Balance and Ventilator Associated Events

NCT ID: NCT05556694

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-18

Study Completion Date

2023-05-18

Brief Summary

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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

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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

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Ventilator Associated Event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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calculation of cumulative fluid balance

\- 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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VAEs assessment

Eligibility Criteria

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Inclusion Criteria

* aged ≥18 years,
* mechanically ventilated for ≥48 h and remain in the intensive care ≥4 days.

Exclusion Criteria

* Patients with acute renal failure and needs dialysis,
* increasing daily minimum positive end-expiratory pressure (PEEP) or Fio2 during MV treatment
* hemodynamic instability
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damanhour University

OTHER

Sponsor Role lead

Responsible Party

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Sahar Younes

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sahar Y Othman, Ass. Prof.

Role: STUDY_CHAIR

Faculty of Nursing, Damanhour University

Locations

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Faculty of nursing

Damanhūr, Behira, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 35356099 (View on PubMed)

Wang 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.

Reference Type BACKGROUND
PMID: 34473657 (View on PubMed)

Chao 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.

Reference Type BACKGROUND
PMID: 30087192 (View on PubMed)

Fang 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.

Reference Type BACKGROUND
PMID: 32728165 (View on PubMed)

Klompas 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.

Reference Type BACKGROUND
PMID: 35589091 (View on PubMed)

Other Identifiers

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ventilator associated events

Identifier Type: -

Identifier Source: org_study_id

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