Protocol summary
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Study aim
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Evaluation of the effect of curcumin piperine supplementation in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
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Design
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This study is a randomized double-blind clinical trial on 50 patients. Randomization is performed by Excel software
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Settings and conduct
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This double-blind study was performed on patients with sepsis in the ICU of Alzahra Hospital in Isfahan. The intervention group received curcumin supplement for 1 week and the control group received malto dextrin supplement for 1 week. In this study, blindness is performed on researchers and patients who participated in the project.
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Participants/Inclusion and exclusion criteria
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Participants: 50 patients aged 20 to 60 years with sepsis admitted to the intensive care unit (ICU)
Inclusion criteria: age 20-60 years, gastrointestinal tract with normal function and diagnosis of sepsis
Non-entry conditions: Impossibility of intestinal feeding in the first 48 hours of admission,
Patients who are expected to die within 12 hours of admission to the intensive care unit. Patients with BMI <18.5 kg / m2 admitted to the intensive care unit.
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Intervention groups
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Group 1) Patients who receive 2 placebo capsules for 7 days, each capsule containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients)
Group 2) Patients receiving two 500 mg capsules of curcumin-piperine per day for 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
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Main outcome variables
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Inflammation and infection in patients with sepsis in the ICU
General information
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Reason for update
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Due to the prevalence of COVID-19 and the allocation of intensive care units (ICUs) to these patients, the duration of the intervention changes from 14 days to 7 days.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150613022681N4
Registration date:
2021-01-02, 1399/10/13
Registration timing:
prospective
Last update:
2022-04-05, 1401/01/16
Update count:
1
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Registration date
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2021-01-02, 1399/10/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-20, 1399/11/01
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Expected recruitment end date
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2021-02-03, 1399/11/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of curcumin piperine supplementation on inflammation, length of stay, and 28-day mortality in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
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Public title
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Evaluation of the effect of curcumin piperine supplementation in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
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Purpose
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Basic scienece
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 20-60 years
Gastrointestinal tract with normal function and intestinal nutrition criteria
Diagnosis of sepsis is based on blood culture and the approval of an ICU, anesthesiologist and infectious disease specialist
Exclusion criteria:
Impossibility of intestinal feeding in the first 48 hours of admission
Any history of underlying heart disease
Patients who are hospitalized in the intensive care unit for less than 48 hours
Patients who are expected to die within 12 hours of admission to the intensive care unit.
Patients who do not have an indication for intestinal nutrition on the first day and are confirmed and predicted based on the diagnosis of the intensive care unit that they will not be able to receive intestinal nutrition in the future. (Nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (> 500 ml per day), high-output fistula (> 500 ml per day), intestinal inaccessibility, incomplete resuscitation and hemodynamic
Patients with BMI <18.5 kg / m2 admitted to the intensive care unit.
Patients who receive nutritional support through complete intravenous feeding
Patients with a history of underlying disease such as diabetes, congenital and immune disorders, renal and hepatic insufficiency, and pancreatitis.
Taking anticoagulants such as heparin, warfarin, aspirin, etc.
Pregnancy and lactation
Severe septic shock or sepsis
Dissatisfaction of the patient or her legal guardian
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Age
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From 20 years old to 75 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be conducted using the block randomization method (permuted blocked randomization). depending on the sample size, each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient.
This will be done using a random number table.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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To blind both patients and investigators, in the beginning, cans containing curcumin supplement and placebo were coded as A and B by a person other than the researcher to ensure the researcher and participants were not informed about the types of supplement received by participants
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-29, 1399/09/09
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Ethics committee reference number
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IR.MUI.MED.REC.1399.759
Health conditions studied
1
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Description of health condition studied
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Sepsis
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ICD-10 code
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A41
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ICD-10 code description
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Other sepsis
Primary outcomes
1
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Description
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Inflammation (via hs-CRP, Albumin, pre Albumin indices)
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Timepoint
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Before and after the intervention
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Method of measurement
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Measurement of inflammatory markers by serum
2
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Description
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mortality 28 days
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Timepoint
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Before and after the intervention
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Method of measurement
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Use official statistics
3
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Description
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Duration of hospitalization
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Timepoint
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Before and after the intervention
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Method of measurement
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Use of questionnaire
Secondary outcomes
1
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Description
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Change in the number of red blood cells
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Timepoint
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Before and after the intervention
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Method of measurement
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Device analysis using cell counter device (hematology analyzer)
2
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Description
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Serum concentration of lipid profiles including triglyceride, cholesterol, HDL, LDL
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Timepoint
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Before and after the intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
3
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Description
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Fasting Blood Sugar Concentration
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Timepoint
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Before and after the intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
4
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Description
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Superoxide dismutase (SOD)
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Timepoint
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Before and after the intervention
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Method of measurement
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Enzymatic method through chemi luminicenece method
5
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Description
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Total Antioxidant Capacity (TAC)
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Timepoint
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Before and after the intervention
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Method of measurement
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Enzymatic method through chemi luminicenece method
6
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Description
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Serum total protein
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Timepoint
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Before and after the intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
7
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Description
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BUN
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Timepoint
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Before and after the intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
8
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Description
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Blood prolactin
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Timepoint
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Before and after the intervention
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Method of measurement
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ELISA method
9
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Description
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serum albumin
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Timepoint
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Before and after the intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
10
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Description
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Serum creatinine
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Timepoint
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Before and after the intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
Intervention groups
1
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Description
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Intervention group: Patients receiving two 500 mg capsules of curcumin-piperine per day for 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
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Category
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Treatment - Drugs
2
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Description
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Control group: Intervention group: Patients receiving 2 placebo capsules for each day containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients) for 7 days
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All data can be shared at the request of individuals
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When the data will become available and for how long
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Six months after publishing the results.
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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Scientific uses
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From where data/document is obtainable
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By sending an email to the following address that belongs to the executor of the project
alikiaiib@med.mui.ac.ir
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What processes are involved for a request to access data/document
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Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.
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Comments
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