Trial Outcomes & Findings for Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III (NCT NCT04507867)
NCT ID: NCT04507867
Last Updated: 2021-10-15
Results Overview
Overall survival, the total number of patients included in the study and completed a 40-day follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
40 days.
Results posted on
2021-10-15
Participant Flow
Participant milestones
| Measure |
Control Group
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
33
|
39
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
Control Group
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Overall Study
Death
|
7
|
1
|
Baseline Characteristics
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
Baseline characteristics by cohort
| Measure |
Control Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Overweight
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Obesity Type I-II
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Diabetes Mellitus 2
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Cardiovascular Disease and/or Hypertension
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Hyperlipidemia
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Number of Participants with Gastrointestinal Disease
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Total Risk Factors
|
2.92 number of risk factors
STANDARD_DEVIATION 1.42 • n=5 Participants
|
2.57 number of risk factors
STANDARD_DEVIATION 1.35 • n=7 Participants
|
2.75 number of risk factors
STANDARD_DEVIATION 1.39 • n=5 Participants
|
|
Number of Participants with Dyspnea
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Nausea and Vomiting
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Hyposmia
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Dysgeusia
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Number of Participants with Headache
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Number of Participants with Myalgia
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Number of Participants with Diarrhea
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Number of Participants with Anorexia
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Total of symptoms
|
7.05 number of symptoms
STANDARD_DEVIATION 2.11 • n=5 Participants
|
6.8 number of symptoms
STANDARD_DEVIATION 2.23 • n=7 Participants
|
6.92 number of symptoms
STANDARD_DEVIATION 2.16 • n=5 Participants
|
|
Bristol scale "normal" (T3-4)
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Number of defecations
|
0.54 Number of defecations per day
STANDARD_DEVIATION 0.6 • n=5 Participants
|
0.52 Number of defecations per day
STANDARD_DEVIATION 0.73 • n=7 Participants
|
0.53 Number of defecations per day
STANDARD_DEVIATION 0.66 • n=5 Participants
|
|
Number of Participants with Abdominal Distension
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Breathing Frequency
|
21.18 breaths per minute
STANDARD_DEVIATION 3.01 • n=5 Participants
|
21.48 breaths per minute
STANDARD_DEVIATION 3.01 • n=7 Participants
|
21.32 breaths per minute
STANDARD_DEVIATION 2.99 • n=5 Participants
|
|
Oxygen Saturation
|
92.73 oxygen saturation percentage
STANDARD_DEVIATION 4.17 • n=5 Participants
|
94 oxygen saturation percentage
STANDARD_DEVIATION 3.18 • n=7 Participants
|
93.36 oxygen saturation percentage
STANDARD_DEVIATION 3.74 • n=5 Participants
|
|
Resting Heart Rate
|
70.7 beats per minute
STANDARD_DEVIATION 15.4 • n=5 Participants
|
75.5 beats per minute
STANDARD_DEVIATION 9.88 • n=7 Participants
|
73.07 beats per minute
STANDARD_DEVIATION 13.07 • n=5 Participants
|
|
Body Temperature (ºC)
|
36.27 degrees Celsius (ºC)
STANDARD_DEVIATION 0.73 • n=5 Participants
|
36.25 degrees Celsius (ºC)
STANDARD_DEVIATION 0.62 • n=7 Participants
|
36.25 degrees Celsius (ºC)
STANDARD_DEVIATION 0.67 • n=5 Participants
|
|
Liters of Supplemental Oxygen
|
5.9 L/min
STANDARD_DEVIATION 3.82 • n=5 Participants
|
6 L/min
STANDARD_DEVIATION 3.29 • n=7 Participants
|
5.97 L/min
STANDARD_DEVIATION 3.54 • n=5 Participants
|
|
qSOFA Score
|
0.425 units on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
|
0.65 units on a scale
STANDARD_DEVIATION 0.62 • n=7 Participants
|
0.53 units on a scale
STANDARD_DEVIATION 0.61 • n=5 Participants
|
|
MNA (Mini Nutritional Assessment) Score
|
11.13 units on a scale
STANDARD_DEVIATION 2.26 • n=5 Participants
|
11.38 units on a scale
STANDARD_DEVIATION 1.65 • n=7 Participants
|
11.25 units on a scale
STANDARD_DEVIATION 1.97 • n=5 Participants
|
|
Body Mass Index (BMI)
|
29.35 kg/m^2
STANDARD_DEVIATION 3.89 • n=5 Participants
|
29.98 kg/m^2
STANDARD_DEVIATION 4.07 • n=7 Participants
|
29.66 kg/m^2
STANDARD_DEVIATION 3.97 • n=5 Participants
|
|
Hydric Balance
|
-203.4 milliliters
STANDARD_DEVIATION 966 • n=5 Participants
|
-301.5 milliliters
STANDARD_DEVIATION 1167 • n=7 Participants
|
-254.1 milliliters
STANDARD_DEVIATION 1056 • n=5 Participants
|
|
Antihypertensive medication
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Antidiabetics medication
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Antilipids medication
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Antibiotics medication
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Antiacids
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
NSAIDs medication
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Hemoglobin
|
15.53 g/dL
STANDARD_DEVIATION 2.22 • n=5 Participants
|
15.54 g/dL
STANDARD_DEVIATION 2.08 • n=7 Participants
|
15.53 g/dL
STANDARD_DEVIATION 2.14 • n=5 Participants
|
|
Mean Corpuscular Hemoglobin Concentration
|
33.39 g/dL
STANDARD_DEVIATION 1.4 • n=5 Participants
|
33.46 g/dL
STANDARD_DEVIATION 1.17 • n=7 Participants
|
33.42 g/dL
STANDARD_DEVIATION 1.28 • n=5 Participants
|
|
Platelets
|
222.2 10^3 platelets / μL
STANDARD_DEVIATION 53.93 • n=5 Participants
|
248.4 10^3 platelets / μL
STANDARD_DEVIATION 139.9 • n=7 Participants
|
235.3 10^3 platelets / μL
STANDARD_DEVIATION 106.1 • n=5 Participants
|
|
Leukocytes
|
8.97 10^3 leukocytes / μL
STANDARD_DEVIATION 4.15 • n=5 Participants
|
8.46 10^3 leukocytes / μL
STANDARD_DEVIATION 4.36 • n=7 Participants
|
8.72 10^3 leukocytes / μL
STANDARD_DEVIATION 4.23 • n=5 Participants
|
|
Neutrophils
|
83.5 percentage
STANDARD_DEVIATION 8.87 • n=5 Participants
|
80.78 percentage
STANDARD_DEVIATION 9.29 • n=7 Participants
|
82.14 percentage
STANDARD_DEVIATION 9.12 • n=5 Participants
|
|
Glycemia
|
135.4 mg/dL
STANDARD_DEVIATION 59.39 • n=5 Participants
|
134.8 mg/dL
STANDARD_DEVIATION 58.83 • n=7 Participants
|
135.12 mg/dL
STANDARD_DEVIATION 58.73 • n=5 Participants
|
|
Total cholesterol
|
142.8 mg/dL
STANDARD_DEVIATION 42.82 • n=5 Participants
|
135 mg/dL
STANDARD_DEVIATION 23.53 • n=7 Participants
|
138.98 mg/dL
STANDARD_DEVIATION 34.65 • n=5 Participants
|
|
Triglycerides
|
147.5 mg/dL
STANDARD_DEVIATION 58.92 • n=5 Participants
|
132.8 mg/dL
STANDARD_DEVIATION 37.39 • n=7 Participants
|
140.2 mg/dL
STANDARD_DEVIATION 49.6 • n=5 Participants
|
|
AST
|
48.06 U/L
STANDARD_DEVIATION 28.81 • n=5 Participants
|
46.4 U/L
STANDARD_DEVIATION 49.65 • n=7 Participants
|
47.2 U/L
STANDARD_DEVIATION 40.3 • n=5 Participants
|
|
ALT
|
47.69 U/L
STANDARD_DEVIATION 31.9 • n=5 Participants
|
50.44 U/L
STANDARD_DEVIATION 50.88 • n=7 Participants
|
49.06 U/L
STANDARD_DEVIATION 42.21 • n=5 Participants
|
|
Albumin
|
3.53 g/dL
STANDARD_DEVIATION 0.44 • n=5 Participants
|
3.57 g/dL
STANDARD_DEVIATION 0.41 • n=7 Participants
|
3.55 g/dL
STANDARD_DEVIATION 0.42 • n=5 Participants
|
|
Ferritin
|
1070 ng/ml
STANDARD_DEVIATION 899.3 • n=5 Participants
|
1270 ng/ml
STANDARD_DEVIATION 1142 • n=7 Participants
|
1167 ng/ml
STANDARD_DEVIATION 1022 • n=5 Participants
|
|
Fibrinogen
|
592.2 mg/dl
STANDARD_DEVIATION 170.4 • n=5 Participants
|
607.4 mg/dl
STANDARD_DEVIATION 162.9 • n=7 Participants
|
600 mg/dl
STANDARD_DEVIATION 165.3 • n=5 Participants
|
|
CRP
|
157.3 mg/l
STANDARD_DEVIATION 106.7 • n=5 Participants
|
135.3 mg/l
STANDARD_DEVIATION 94.92 • n=7 Participants
|
146.3 mg/l
STANDARD_DEVIATION 100.9 • n=5 Participants
|
|
D dimer
|
291.2 μg/ml
STANDARD_DEVIATION 179.9 • n=5 Participants
|
444.9 μg/ml
STANDARD_DEVIATION 954.9 • n=7 Participants
|
368 μg/ml
STANDARD_DEVIATION 686.4 • n=5 Participants
|
|
Serum Creatinine
|
0.88 mg/dl
STANDARD_DEVIATION 0.31 • n=5 Participants
|
0.86 mg/dl
STANDARD_DEVIATION 0.22 • n=7 Participants
|
0.87 mg/dl
STANDARD_DEVIATION 0.27 • n=5 Participants
|
|
Urea
|
33.95 mg/dl
STANDARD_DEVIATION 15.84 • n=5 Participants
|
32.95 mg/dl
STANDARD_DEVIATION 10.78 • n=7 Participants
|
33.42 mg/dl
STANDARD_DEVIATION 13.47 • n=5 Participants
|
|
Blood urea nitrogen (BUN)
|
15.87 mg/dl
STANDARD_DEVIATION 7.39 • n=5 Participants
|
15.43 mg/dl
STANDARD_DEVIATION 5.02 • n=7 Participants
|
15.65 mg/dl
STANDARD_DEVIATION 6.29 • n=5 Participants
|
|
Glomerular filtration rate (GFR)
|
90.15 mL/min/1.73 m^2
STANDARD_DEVIATION 20.2 • n=5 Participants
|
93.59 mL/min/1.73 m^2
STANDARD_DEVIATION 17.4 • n=7 Participants
|
91.84 mL/min/1.73 m^2
STANDARD_DEVIATION 18.82 • n=5 Participants
|
|
Procalcitonin
|
0.364 μg/L
STANDARD_DEVIATION 0.6 • n=5 Participants
|
0.18 μg/L
STANDARD_DEVIATION 0.188 • n=7 Participants
|
0.27 μg/L
STANDARD_DEVIATION 0.45 • n=5 Participants
|
|
basal energy intake
|
1411 kilocalories
STANDARD_DEVIATION 46.2 • n=5 Participants
|
1376 kilocalories
STANDARD_DEVIATION 36.3 • n=7 Participants
|
1393.5 kilocalories
STANDARD_DEVIATION 43.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 40 days.Population: the total number of patients who were enrolled and included in the study and who survived or not at the end of follow-up at day 40.
Overall survival, the total number of patients included in the study and completed a 40-day follow-up.
Outcome measures
| Measure |
Control Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Overall Survival
|
33 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: 40 days.Population: total number of patients who were enrolled in the study and died prior to day 40 of follow-up
Total number of patients who died before day 40 of follow-up.
Outcome measures
| Measure |
Control Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Overall Mortality at Day 40
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 40 daysTotal number of patients who were intubated, extubated, discharged and completes the 40 day follow-up
Outcome measures
| Measure |
Control Group
n=7 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=3 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Survival in Intubated Patients at Day 40
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 40 daysPatients who were intubated during their hospital stay and died before completing follow-up on day 40.
Outcome measures
| Measure |
Control Group
n=7 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=3 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Mortality in Intubated Patients at Day 40
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 10 days.Population: Proportion of patients from control group and intervention group were analyzed with the Kaplan-Meier method comparing both groups to MVA progression
total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay.
Outcome measures
| Measure |
Control Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Progression to Mechanical Ventilation Assistance
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: day 3Population: Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay . Deceased patients were excluded.
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".
Outcome measures
| Measure |
Control Group
n=24 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=31 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Participants With Normal Bristol Scale at Day 3
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.
The ratio between the water assimilated into the body and that lost from the body, in milliliters.
Outcome measures
| Measure |
Control Group
n=17 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=18 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Hidric Balance on Day 3
|
123.4 milliliters
Standard Deviation 453.8
|
456.6 milliliters
Standard Deviation 485.5
|
SECONDARY outcome
Timeframe: day 3.Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.
the total number of patients with oxygen saturation \>90% on day 3 of their hospital stay.
Outcome measures
| Measure |
Control Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Oxigen Saturation >90% on Day 3
|
34 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: baseline and hospital dischargePopulation: Intragroup analysis between the control group and the intervention group for different parameters, measured at baseline and at hospital discharge.
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.
Outcome measures
| Measure |
Control Group
n=6 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=10 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
PHQ-9 Test
Baseline
|
3.66 score on a scale
Standard Deviation 2.5
|
5.3 score on a scale
Standard Deviation 3.4
|
|
PHQ-9 Test
Hospital discharge
|
1.50 score on a scale
Standard Deviation 2.8
|
1.9 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: baseline and day 3Population: Intragroup and Intergroup analysis between the control group and the intervention group for the difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group.
Difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group.
Outcome measures
| Measure |
Control Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Oxigen Flow (Intragroup)
Baseline
|
5.9 Liters (L)
Standard Deviation 3.8
|
6 Liters (L)
Standard Deviation 3.2
|
|
Oxigen Flow (Intragroup)
Day 3
|
6 Liters (L)
Standard Deviation 4.4
|
4.5 Liters (L)
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline and Day 3Population: Intragroup analysis of both groups, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.
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.
Outcome measures
| Measure |
Control Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=40 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
qSOFA at Day 3
Baseline
|
0.42 score on a scale
Standard Deviation 0.59
|
0.65 score on a scale
Standard Deviation 0.62
|
|
qSOFA at Day 3
Day 3
|
0.51 score on a scale
Standard Deviation 0.57
|
0.43 score on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Day 3Population: Intergroup analysis between both groups to evaluate the number of defecations measured at 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.
Outcome measures
| Measure |
Control Group
n=37 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=36 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Number of Defectations on Day 3
|
0.81 defecations
Standard Deviation 0.90
|
1.41 defecations
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Day 3Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay. Deceased patients were excluded.
Is a visible increase in abdominal girth.1. Present, 2. Absent.
Outcome measures
| Measure |
Control Group
n=31 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=31 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Number of Participants With Distension on Day 3
|
51.6 percent of participants
|
19.4 percent of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 40Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.
The oxygen saturation without supplementary oxygen is taken at the control appointment 40 days after hospital discharge.
Outcome measures
| Measure |
Control Group
n=28 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=38 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Saturation Without Supplementary Oxygen
|
90.39 percentage
Standard Deviation 3.4
|
92.08 percentage
Standard Deviation 2.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 40Population: Intragroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days of hospital stay. Deceased patients were excluded.
The need to continue with supplemental oxygen at hospital discharge. Categories: 1. Yes, 2. No.
Outcome measures
| Measure |
Control Group
n=27 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=39 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Need for Home Oxygen Flow
|
23 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 40Population: Intragroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded
It is recorded for how many days the treating doctor asked the patients to continue to administer supplemental oxygen after hospital discharge
Outcome measures
| Measure |
Control Group
n=17 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=23 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Time of Home Oxigen Use
|
57.6 days
Standard Deviation 24.6
|
43.8 days
Standard Deviation 16.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 40.Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.
Persistence of clinical signs and symptoms that arise after developing COVID-19, and are not explained by an alternative diagnosis. 1. Present. 2. Absent.
Outcome measures
| Measure |
Control Group
n=24 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=34 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Post Covid Syndrome
|
9 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 40Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.
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
Outcome measures
| Measure |
Control Group
n=11 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=18 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Weight Decrease
|
8 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 40Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.
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)
Outcome measures
| Measure |
Control Group
n=24 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=37 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Gastrointestinal Symptoms
|
4 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
Association between the presentation of certain laboratory parameters taken at baseline with the overall mortality of discharged patients compared to deceased patients.
Outcome measures
| Measure |
Control Group
n=61 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=19 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Number of Deceased Patients Stratified by Fibrinogen Level.
|
2 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
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
Outcome measures
| Measure |
Control Group
n=72 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=8 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Number of Deceased Patients Stratified by Procalcitonin Level.
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
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
Outcome measures
| Measure |
Control Group
n=71 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=9 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Number of Deceased Patients Stratified by Ureic Nitrogen Level
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
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
Outcome measures
| Measure |
Control Group
n=45 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=35 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Number of Deceased Participants Stratified by RCP Level
|
1 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
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
Outcome measures
| Measure |
Control Group
n=27 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=53 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Number of Deceased Participants Stratified by Neutrophils Level
|
0 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
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
Outcome measures
| Measure |
Control Group
n=57 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=23 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Number of Deceased Participants Stratified by Leukocytes Level
|
3 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
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
Outcome measures
| Measure |
Control Group
n=64 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=16 Participants
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Number of Deceased Participants Stratified by Urea Level
|
4 Participants
|
4 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Intervention Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=40 participants at risk
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
|
Intervention Group
n=40 participants at risk
Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40 • 40 days.
Adverse Events and All Cause Mortality monitored for 40 days.
|
12.5%
5/40 • Number of events 5 • 40 days.
Adverse Events and All Cause Mortality monitored for 40 days.
|
Additional Information
Dr. Fernando Leal Martínez
Universidad Anáhuac México Norte
Phone: +52 5521094339
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place