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A study to understand the role of kidney in handling cytokines and oxidative stress in severe infection.

Role of kidney in handling cytokines and oxidative stress in sepsis:A Prospective Study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/05/110478
Enrollment
80
Registered
2026-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N179- Acute kidney failure, unspecified Health Condition 2: A419- Sepsis, unspecified organism

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

Varaparla Grace Mercy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18 to 65years of either gender who are willing to give informed consent. 2.Healthy Controls refers to individuals without any known diseases or conditions, used as a comparison group in the study to assess differences in biological markers and outcomes between affected individuals and unaffected individuals. 3.Sepsis, defined by Sepsis-3 Criteria, with at least two of these three clinical variables may be prone for the outcome typical of Sepsis. 1.Low Blood pressure (SB P less than or equal to 100mmHg) 2. High Respiratory Rate greater than or equal to 22breathsper min), or 3. altered mentation Glasgow Coma Scale less than 15(quick SOFA). And Sepsis-3 criteria: i.Suspected infection: A suspected infection is present. ii.Sequential Organ Failure Assessment (SOFA): There is an acute increase of at least 2 points in the SOFA score. iii.Septic shock: There is a vasopressor infusion and a serum lactate concentration of at least 2.0 mmolper L. iv.Severity of sepsis defined by SOFA Score. 4.Sepsis Associated Acute Kidney Injury(SA-AKI) defined by Acute Disease Quality Initiative (ADQI) as occurrence of AKI within 7days of sepsis onset and Sepsis defined by Sepsis-3 Criteria. 5.Acute Kidney Injury(AKI) defined by Kidney Disease Improving Global Outcomes (KDIGO). i. A serum creatinine (S Cr) increase of at least 0.3 mg per dL within 48 hours. ii. An S Cr increase to at least 1.5 times baseline within the last 7 days. iii. A urine output of less than 0.5 mLper kg per h for at least 6 hours.

Exclusion criteria

Exclusion criteria: 1.ICU hospital stay less than 24 hours stay 2.Active connective tissue disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) 3.Pregnancy or breastfeeding patients 4.Previous hematological malignancies 5.Received radiotherapy or chemotherapy in the past 30 days; 6.Received immunosuppressive drugs in the past 30 days or received continuous treatment of more than 10 mg of prednisolone per day (or other hormones at the same dose); 7.Participated in clinical studies on related drugs or devices affecting immunity in the past 30 days. 8.Post-surgery (those who are on medication) 9.IVIG patients 10.Chronic Renal Failure(CRF)/Chronic Kidney Disease(CKD)

Design outcomes

Primary

MeasureTime frame
1.Renal outcomes by patients with Sepsis Associated Acute Kidney Injury (SA-AKI) will show reduced urinary cytokine levels, elevated serum cytokine levels and higher oxidative stress markers associated with need for Renal Replacement Therapy (RRT) or persistent Acute Kidney Injury(AKI)or Acute Kidney Disease(AKD).Timepoint: 90 Days

Secondary

MeasureTime frame
2.Patient outcomes by higher serum cytokines and oxidative stress correlated with mortality, ventilator or ionotropic support required and prolonged Intensive Care Unit stay. 3.Mechanistic outcome by cytokine clearance and serum-to-urine ratios as potential biomarkers for early detection and prognosis of Sepsis Associated Acute Kidney Injury (SA-AKI) . Timepoint: 90 Days

Countries

India

Contacts

Public ContactVaraparla Grace Mercy

Nizams Institute of Medical Sciences

cptnims@gmail.com7416512888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026