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Preoperative immunonutrition on postoperative acute kidney injury in patients with advanced gastrointestinal tumors combined with moderate to severe malnutrition: a multicenter, randomized, single-blind superiority study

Preoperative immunonutrition on postoperative acute kidney injury in patients with advanced gastrointestinal tumors combined with moderate to severe malnutrition: a multicenter, randomized, single-blind superiority study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123747
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Acute kidney injury

Interventions

Immunonutrition Group:Basal Components:Total Energy Target: 25–30 kcal/kg/d.Protein Target: 1.5 g/kg/d. Core Immune-Enhancing Components:Arginine: 8–10 g/d.?-3 Fatty Acids (EPA+DHA): 2.0–3.0 g/d.Nucle
Standard Nutrition Group:The control group receives a Standard Nutrition (SN) protocol designed on the "isocaloric, isonitrogenous, and isovolumetric" principle to eliminate non-specific benefits from

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 75 years old (inclusive); 2. Surgical Plan: Scheduled to undergo elective gastrointestinal tumor resection; 3. Nutritional Status: Diagnosed with moderate-to-severe malnutrition according to ESPEN standards (with a Subjective Global Assessment [SGA] score >= 4); 4. Informed Consent: Signed the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Emergency or Palliative Surgery: Patients undergoing emergency surgery or palliative procedures. 2. Nephrotoxic Chemotherapy: Patients who have received nephrotoxic chemotherapy (e.g., cisplatin) within the past 4 weeks. 3. Severe Renal Impairment: Patients with stage 4-5 chronic kidney disease (CKD) or those requiring dialysis. 4. Severe Liver Dysfunction: Patients with severe liver impairment (Child-Pugh Class C). 5. Immune System Conditions: Patients with active autoimmune diseases or those on long-term immunosuppressive therapy. 6. Low Baseline eGFR: Patients with a preoperative estimated glomerular filtration rate (eGFR) <=45 ml/min/1.73m² (calculated using the CKD-EPI formula). 7. Seafood Allergies: Patients with severe allergies to fish, shrimp, or other seafood products.

Design outcomes

Primary

MeasureTime frame
Incidence of Acute Kidney Injury (AKI) within 7 days postoperatively;Nutrition-related Adverse Reactions;—

Secondary

MeasureTime frame
AKI Severity (Maximum KDIGO Stage);Peak Renal Injury Biomarker (NGAL);Postoperative Length of Stay (LOS);Postoperative 30-day All-cause Mortality;—

Countries

China

Contacts

Public ContactYousheng Li

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

gisurgery@qq.com+86 138 0902 8387

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026