Curcumin in Critically Ill Patients With Sepsis
ConditionSepsis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Civil de Guadalajara
About this trial
Sepsis is a life-threatening condition that occurs when the body's response to an infection becomes overwhelming and damages its own organs. It is one of the leading causes of death in critically ill (very sick) patients worldwide. Despite advances in antibiotics, intensive care, and life-support technologies, sepsis remains difficult to treat because much of the harm comes not only from the infection itself, but from an exaggerated and uncontrolled inflammatory response in the body. When a person develops sepsis, the immune system releases large amounts of inflammatory substances meant to fight infection. However, in many cases this response becomes excessive, leading to organ failure, prolonged stays in the intensive care unit (ICU), and increased risk of death. Current treatments focus mainly on controlling the infection and supporting failing organs, but there are limited therapies that directly help regulate this harmful immune overreaction. Curcumin is a natural compound found in turmeric, a spice commonly used in food. In laboratory studies and some clinical research, curcumin has shown anti-inflammatory and antioxidant properties. It appears to influence several pathways in the immune system that are involved in the inflammatory process. However, its potential benefits in patients with severe infections such as sepsis have not been fully studied in a rigorous clinical setting. The purpose of this clinical trial is to evaluate whether curcumin, when added to standard medical treatment, can help modulate (regulate) the immune response in critically ill patients with sepsis. This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" in Guadalajara, Mexico. "Randomized" means that participants will be assigned by chance to receive either curcumin or a placebo (a look-alike substance that contains no drug). "Double-blind" means that neither the patients nor the healthcare team will know who is receiving curcumin and who is receiving the placebo during the study. This design helps ensure that the results are objective and scientifically reliable. Participants in the study will continue to receive all standard treatments for sepsis, including antibiotics and intensive care support. The study will measure inflammatory markers in the blood, organ function, and important clinical outcomes such as the need for organ support and length of stay in the ICU. Safety will also be carefully monitored.
Hypothesis:
The investigators hypothesize that in critically ill patients with sepsis, the addition of curcumin to standard treatment will help regulate the excessive inflammatory response, leading to improved biological markers of inflammation and potentially better clinical outcomes, compared to standard treatment alone. If curcumin proves to be beneficial and safe in this population, it could represent an accessible and relatively low-cost complementary therapy to improve the management of sepsis. However, this study is necessary to determine scientifically whether these potential benefits are real and clinically meaningful. The ultimate goal of this research is to contribute new evidence that may improve the care and survival of patients suffering from one of the most severe and challenging conditions treated in intensive care medicine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years of either sex.
Critically ill patients with a diagnosis of sepsis admitted to the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde."
Patients receiving enteral nutrition.
Written informed consent signed by the patient or their legally authorized representative.
Disqualifiers
Patients with a history of allergy or hypersensitivity to curcumin.
Patients with autoimmune diseases or severe immunosuppression.
Patients in a terminal condition with a life expectancy of less than 48 hours.
Patients with intolerance to enteral feeding, intestinal ischemia, intestinal obstruction, pancreatitis or short bowel syndrome.
Trial design
Design model
Parallel
Treatments tested in this trial
Curcumin
Dietary supplementThe investigational product consists of an oral, enhanced-bioavailability formulation of curcumin (Longvida®). Each capsule contains 500 mg of formulation standardized to 20% curcumin, providing 100 mg of active curcumin per capsule. Participants assigned to the experimental arm will receive 2 capsules three times daily (every 8 hours) for 10 consecutive days, for a total of 6 capsules per day and 600 mg of curcumin daily.
Placebo
DrugParticipants randomized to this arm will receive standard-of-care treatment for sepsis plus a matched placebo administered enterally. The placebo consists of starch-based capsules identical in appearance to the active product. Patients will take 2 placebo capsules three times daily for 10 days (total 6 capsules/day), following the same schedule as the experimental arm, while all other treatment remains at the discretion of the treating team.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Curcumin + Standard of CareExperimental treatment 1 intervention
Group B: Placebo + Standard of CarePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Interleukin-6 (IL-6) from baseline to Day 10 of treatment.
Serum concentrations of the pro-inflammatory cytokine interleukin-6 (IL-6, pg/mL) will be measured in peripheral venous blood samples collected at baseline (prior to initiation of the intervention) and on Day 10 of treatment. Samples will be processed under standardized laboratory conditions and analyzed using validated quantitative immunoassay techniques (enzyme-linked immunosorbent assay \[ELISA\]). Results will be reported in pg/mL. The primary endpoint will be defined as the change in cytokine levels from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in circulating cytokine concentrations will be interpreted as evidence of a modulatory effect on the systemic inflammatory response associated with sepsis.
Time frame
Baseline to Day 102
Change in Interleukin-1 beta (IL-1β) from baseline to Day 10 of treatment.
Serum concentrations of the pro-inflammatory cytokine interleukin-1 beta (IL-1β, pg/mL), will be measured in peripheral venous blood samples collected at baseline (prior to initiation of the intervention) and on Day 10 of treatment. Samples will be processed under standardized laboratory conditions and analyzed using validated quantitative immunoassay techniques (enzyme-linked immunosorbent assay \[ELISA\]). Results will be reported in pg/mL. The primary endpoint will be defined as the change in cytokine levels from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in circulating cytokine concentrations will be interpreted as evidence of a modulatory effect on the systemic inflammatory response associated with sepsis.
Time frame
Baseline to Day 103
Change in tumor necrosis factor-alpha (TNF-α) from baseline to Day 10 of treatment.
Serum concentrations of the pro-inflammatory cytokine tumor necrosis factor-alpha (TNF-α, pg/mL) will be measured in peripheral venous blood samples collected at baseline (prior to initiation of the intervention) and on Day 10 of treatment. Samples will be processed under standardized laboratory conditions and analyzed using validated quantitative immunoassay techniques (enzyme-linked immunosorbent assay \[ELISA\]). Results will be reported in pg/mL. The primary endpoint will be defined as the change in cytokine levels from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in circulating cytokine concentrations will be interpreted as evidence of a modulatory effect on the systemic inflammatory response associated with sepsis.
Time frame
Baseline to Day 10Secondary outcomes
1
Change in high-sensitivity C-reactive protein (hs-CRP) from baseline to Day 10 of treatment.
Serum levels of high-sensitivity C-reactive protein (hs-CRP, mg/L) will be measured at baseline (prior to initiation of the intervention) and on Day 10 of treatment. hs-CRP will be quantified using standardized automated immunoassays. Results will be reported in mg/L. The secondary endpoint will be defined as the change in hs-CRP from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in hs-CRP will be interpreted as evidence of attenuation of systemic inflammation.
Time frame
Baseline to Day 102
Change in procalcitonin (PCT) from baseline to Day 10 of treatment.
Serum levels of procalcitonin (PCT, ng/mL) will be measured at baseline (prior to initiation of the intervention) and on Day 10 of treatment. PCT will be quantified using standardized automated immunoassays. Results will be reported in ng/mL. The secondary endpoint will be defined as the change in PCT from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in PCT will be interpreted as evidence of attenuation of systemic inflammation.
Time frame
Baseline to Day 103
Change in erythrocyte sedimentation rate (ESR) from baseline to Day 10 of treatment.
Serum levels of erythrocyte sedimentation rate (ESR, ng/mL), will be measured at baseline (prior to initiation of the intervention) and on Day 10 of treatment. ESR will be determined using conventional laboratory methodology (Westergren method). Results will be reported in ng/mL. The secondary endpoint will be defined as the change in ESR from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in ESR will be interpreted as evidence of attenuation of systemic inflammation.
Time frame
Baseline to Day 104
Days of Hospital Length of Stay and Days of ICU Length of Stay
Clinical evolution will be evaluated by measuring total hospital length of stay, defined as the number of days from hospital admission to discharge, and ICU length of stay, defined as the number of days from ICU admission to ICU discharge, both reported in days. These outcomes will be compared between the curcumin and placebo groups to determine differences in clinical recovery.
Time frame
From date of enrollment until the date of hospital discharge; assesed up to 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Civil de Guadalajara
Lead sponsor
University of Guadalajara
Collaborator
Source ClinicalTrials.gov