Trial · NCT05979038
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 28 days mortality | 28 days | Patients mortality rate and time from ICU admission till death due to any cause will be assessed within 28 days even after discharge from the ICU. |
| Secondary | 2.Total ICU lengths of stay: | 28 days | The number of days that the patient will stay in the ICU will be calculated. |
| Secondary | 3.Arterial blood gases (ABG): | 28 days | ABG will be measured daily for every patient throughout his/her stay in the ICU. The total number of days that ABG are abnormal will be calculated for every patients in order to get the number of abnormal readings and check after how long ABG returned to normal |
| Secondary | 4- Serum TNF alpha: | 28 days | Blood samples will be withdrawn at baseline and day ten of ICU admission from every patient included in the study to measure TNF alpha. Samples will be stored in -80C and will be assessed using ELISA technique. |
| Secondary | 5- Total Leucocytic Count (TLC): | 28 days | Blood samples will be withdrawn daily from every patient included in the study to measure TLC. The total number of days that TLC is high will be calculated for every patients in order to get the number of abnormal readings and check after how long TLC returned to normal ( 4000 to 11,000/microliters). |
| Secondary | 6- Sequential organ Failure assessment Scores (SOFA): | 28 days | SOFA score will be calculated daily for every patient to assess organ failure and recovery. Sequential Organ Failure Assessment score (SOFA) is a scoring system used to evaluate organ failure. The score is based on six different scores: respiratory, cardiovascular, hepatic, coagulation, renal and neurological system. It calculates the degree of organ failure by assigning a point of 0 (normal) to 4 (failure) for each organ. Score ranges from 0 (best) to 24 (worst) points. For calculating SOFA score the below table 1 will be used:(Singer et al., 2016a) |
| Secondary | 7- APACHE II Score: | 28 days | APACH II score will be calculated daily for every patient to assess disease severity. The score can help in the assessment of patients to determine the level \& degree of diagnostic \& therapeutic intervention. Score ranges from minimum 0 and maximum 71; increasing score is associated with an increasing risk of hospital death. For calculating APACHE score, below table will be used (Akavipat, 2019) |
| Secondary | 8-GCS Score: | 28 days | Glasgow Coma scale (GCS) will be calculated daily to assess patient's consciousness. It is scored between 3 and 15, with 3 being the worst and 15 the best. It is composed of 3 parameters: best eye response (E), best verbal response (V), and best motor response (M). A score of 13 or higher correlates with mild brain injury, a score of 9 to 12 correlates with moderate injury, and a score of 8 or less represents severe brain injury (Teasdale and Jennett, 1974). |
| Secondary | 9-28 days Readmission: | 28 days | The number of patients who were discharged from the ICU and returned again within 28 days will be calculated |
| Secondary | 10-Blood Pressure | 28 days | All patients included in the study will be monitored 24 hours a day (24/24) by putting them on a vital signs monitor in order to follow up their blood pressure. The total number of abnormal blood pressure measurements will be calculated for every patient. Mean arterial blood pressure will also be calculated (target is 65 mm Hg) and the total number of days patient will need a vasopressor will be calculated and doses of vasopressor will be documented. |
| Secondary | 11-Mechanical Ventilation: | 28 days | Number of patients who will need mechanical ventilation will be calculated. In addition, ventilation free days will be assessed for every patient. |
| Secondary | 12-Serum Lactate levels: | 28 days | Blood samples will be withdrawn every other day from every patient included in the study to measure serum lactate levels. The lactate cutoffs determining an elevated level ranged from 1.6-2.5 mmol/L (Evans et al., 2021). Patients with elevated serum lactate levels will be closely monitored. The number of days that serum lactate levels are high will be calculated for every patient throughout the study |
| Secondary | GIT Disturbances: | 28 days | Patient will be interviewed for the incidence of nausea, vomiting or diarrhea. If patient cannot reply (low conscious level), nurses will be asked. The total number of days that patient will suffer any of the GIT disturbances will be calculated and documented. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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