Obesity Clinical Trial
Official title:
Effect of a Nutritional Support System to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
NCT number | NCT04507867 |
Other study ID # | 202036 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 7, 2020 |
Est. completion date | April 10, 2021 |
Verified date | October 2021 |
Source | Anahuac University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The disease caused by SARS-CoV-2, has derived a pandemic in which its evolution and complications depend on the immune capacity of the host. The virus has been characterized by presenting an inflammatory cascade, increased by the overproduction of proinflammatory cytokines, the decrease in metalloenzymes and also the rapid spread of the virus. There are several lines of treatment, however, nutritional treatment only considered a caloric intake. For this reason, this study will evaluate the evolution of patients with COVID-19 assisted by nutritional support system and the effect of this therapy in reducing complications and comorbidities. Research question: Will the nutritional support system reduce complications in stage III positive COVID-19 patients with comorbidities (type 2 DM, SAH, overweight / obesity with BMI <35), with a better benefit than that achieved with the conventional nutritional treatment ?. Hypothesis: The nutritional support system will reduce the complications of patients with COVID-19 in stage III with comorbidities. General Objective: To determine the effect of the use of a nutritional support system on complications in patients with COVID-19 in stage III with comorbidities. Methodology: A controlled, blinded, randomized clinical trial will be conducted in patients with COVID-19, hospitalized at the ISSEMYM Toluca Arturo Montiel Rojas Medical Center, who meet the inclusion criteria. The evolution of the group of patients receiving the nutritional support system (NSS) and the normal diet implemented by the hospital will be evaluated against the group of patients receiving only the diet, using clinical examination, laboratory and cabinet tests during their hospital stay. Statistical analysis: for independent groups with normal distribution, Student's T will be applied. If the distribution does not meet normality criteria, a Mann Whitney U will be performed; Two-way ANOVA will be applied to monitor the groups over time with normal distribution. If the distribution does not meet normality criteria, a Friedman test will be performed, in both cases post hoc tests will be performed. The results will be analyzed using version 6 of the Graphpad Prism software.
Status | Completed |
Enrollment | 80 |
Est. completion date | April 10, 2021 |
Est. primary completion date | April 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients admitted to the ISSEMYM Toluca Medical Center "Arturo Montiel Rojas ", diagnosed with COVID-19 confirmed by PCR. - Patients in need of supplemental O2 with nasal prongs or reservoir-mask for satO2 <90% and respiratory distress. - With concomitant diseases such as cardiovascular disease, diabetes mellitus 2, hypertension, overweight or obesity BMI <35. - Both sexes. - Over 30 years old. - The patient tolerate oral feeding. - Signing of the letter of informed consent. Exclusion Criteria: - Detachment from treatment. - Admission to the ICU for any reason. - Patients who do not tolerate the oral route. - Reactions to treatment that compromise the health of patients. |
Country | Name | City | State |
---|---|---|---|
Mexico | ISSEMYM "Arturo Montiel Rojas" Medical Center | Toluca de Lerdo | Mexico State |
Lead Sponsor | Collaborator |
---|---|
Anahuac University |
Mexico,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Saturation Without Supplementary Oxygen | The oxygen saturation without supplementary oxygen is taken at the control appointment 40 days after hospital discharge. | day 40 | |
Other | Need for Home Oxygen Flow | The need to continue with supplemental oxygen at hospital discharge. Categories: 1. Yes, 2. No. | Day 40 | |
Other | Time of Home Oxigen Use | It is recorded for how many days the treating doctor asked the patients to continue to administer supplemental oxygen after hospital discharge | day 40 | |
Other | Post Covid Syndrome | Persistence of clinical signs and symptoms that arise after developing COVID-19, and are not explained by an alternative diagnosis. 1. Present. 2. Absent. | Day 40. | |
Other | Weight Decrease | Is defined as at least a 5% reduction in weight from the baseline level.Total number of patients with weight loss at the end of follow-up at day 40 | Day 40 | |
Other | Gastrointestinal Symptoms | Total number of patients with gastrointestinal symptoms at the end of follow-up at day 40.Those symptoms perceived abdominal region (pain, burn, pressure, nausea, vomiting) | Day 40 | |
Other | Number of Deceased Patients Stratified by Fibrinogen Level. | Association between the presentation of certain laboratory parameters taken at baseline with the overall mortality of discharged patients compared to deceased patients. | Baseline | |
Other | Number of Deceased Patients Stratified by Procalcitonin Level. | Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients | Baseline | |
Other | Number of Deceased Patients Stratified by Ureic Nitrogen Level | Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients | Baseline | |
Other | Number of Deceased Participants Stratified by RCP Level | Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients | Baseline | |
Other | Number of Deceased Participants Stratified by Neutrophils Level | Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients | Baseline | |
Other | Number of Deceased Participants Stratified by Leukocytes Level | Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients | Baseline | |
Other | Number of Deceased Participants Stratified by Urea Level | Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients | Baseline | |
Primary | Overall Survival | Overall survival, the total number of patients included in the study and completed a 40-day follow-up. | 40 days. | |
Primary | Overall Mortality at Day 40 | Total number of patients who died before day 40 of follow-up. | 40 days. | |
Secondary | Survival in Intubated Patients at Day 40 | Total number of patients who were intubated, extubated, discharged and completes the 40 day follow-up | 40 days | |
Secondary | Mortality in Intubated Patients at Day 40 | Patients who were intubated during their hospital stay and died before completing follow-up on day 40. | 40 days | |
Secondary | Progression to Mechanical Ventilation Assistance | total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay. | 10 days. | |
Secondary | Participants With Normal Bristol Scale at Day 3 | The Bristol Stool Form Scale categorizes stools into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhea). Type 3 and 4 were considered "Normal". | day 3 | |
Secondary | Hidric Balance on Day 3 | The ratio between the water assimilated into the body and that lost from the body, in milliliters. | It is evaluated on day 3 of hospital stay (duration approximately 10 minutes). | |
Secondary | Oxigen Saturation >90% on Day 3 | the total number of patients with oxygen saturation >90% on day 3 of their hospital stay. | day 3. | |
Secondary | PHQ-9 Test | Is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders, includes 9 items, which evaluate the presence of depressive symptoms based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders version 4, during the last 2 weeks, how often the patient presented depressive symptoms. According to the sum of the score obtained, the following 4 categories will be considered: 0-4 minimum existence or absence of depressive symptoms; 5-9 = mild depressive symptoms; 10-14 = moderate depressive symptoms; 15-19 = moderate to severe depressive symptoms; 20-27 = severe depressive symptoms. | baseline and hospital discharge | |
Secondary | Oxigen Flow (Intragroup) | Difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group. | baseline and day 3 | |
Secondary | qSOFA at Day 3 | Quick-Sequential Organ Failure Assessment (qSOFA) score gives 0 to 3 points. =2 in the setting of suspected infection had a high predicted in-hospital mortality rate and could be considered septic. | Baseline and Day 3 | |
Secondary | Number of Defectations on Day 3 | Refers to the subjective sensation of increased abdominal pressure without an increase in abdominal size, the number of defecations were quantified at day 3 and compared between both groups. | Day 3 | |
Secondary | Number of Participants With Distension on Day 3 | Is a visible increase in abdominal girth.1. Present, 2. Absent. | Day 3 |
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