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Effects of adequate amino acid administration on clinical outcomes after major gastrointestinal surgery: a single-center, prospective, randomized, controlled study

Effects of adequate amino acid administration on clinical outcomes after major gastrointestinal surgery: a single-center, prospective, randomized, controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056258
Enrollment
Unknown
Registered
2022-02-03
Start date
2022-02-15
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Gastrointestinal diseases

Interventions

Experimental group :Adequate amino acids after surgery
control group :Routine nutrition program

Sponsors

Shandong First Medical University Affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 18-80; 2. Non-traumatic elective surgery patients; 3. Patients with gastrointestinal tumor resection (including total stomach/distal stomach/proximal stomach/right hemicolon/transverse colon/left hemicolon/sigmoid colon/rectum); 4. Vital signs are stable; 5. Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Mentally ill or unable to work with others; 2. Pregnant or lactating women; 3. Unstable vital signs or hemodynamics (e.g., systolic blood pressure & LT after rapid infusion of 500ml crystal or 200ml colloid; 90 mmHg or mean arterial pressure <70mmHg, or 50% increase in vasoactive drug infusion rate within 1 hour, etc.); 4. Unwilling to participate in this study; 5. Malignant or irreversible diseases with an expected death rate of more than 50 per cent within six months; (1) HIV positive patients with end-stage or CD4 count less than 50/mm^3; (2) Patients who received CARD Iopulmonary resuscitation before cardiac arrest and whose nervous system function was not fully recovered; (3) Class iv patients with limited physical activity as defined by the New York Cardiology Association; (4) Patients who cannot be taken off the ventilator due to chronic diseases; 6. Dying patients with a life expectancy of less than 24 hours; 7. Refractory shock, satisfying any of the following: (1) Dopamine infusion rate was greater than 15 ug/kg/min; (2) Dobutamine infusion rate was greater than 15 ug/kg/min; (3) The infusion rate of epinephrine or norepinephrine is greater than 30 ug/min; (4) The infusion rate of phenylephrine was greater than 50 ug/min; (5) The infusion rate of milidone was greater than 0.5ug /kg/min; (6) Vasopressin infusion rate was greater than 0.04 U/min; (7) balloon counter pulsation; 8. Severe liver insufficiency (Liver function score 11-15 or total bilirubin & GT;3mg/dL or biopsy diagnosis of cirrhosis, hepatic encephalopathy, portal hypertension with a history of gastrointestinal bleeding, etc.); 9. Severe renal insufficiency (creatinine more than 2 times the upper normal limit); 10. Severe metabolic diseases (such as metabolic syndrome, hyperthyroidism, ketoacidosis, etc.); 11. Patients with burns over 20% of their body surface area; 12. Immune deficiency, immunosuppressive or autoimmune diseases (e.g., patients who have had allogeneic bone marrow transplantation in the last five years, taking immunosuppressive drugs, SLE, etc.); 13. International standardized ratio (INR) greater than 3.0 or platelet count less than 30,000/mm3 or history of other hemorrhagic diseases; 14. Intracranial hemorrhage one month before enrollment; 15. Allergies to enteral or parenteral nutrition formulations; 16. Have been enrolled in other clinical studies or have been enrolled in this study; 17. Patients started nutritional support therapy before enrollment; 18. Patients who underwent surgery again during the intervention period after enrollment; 19. Severe hyperglycemia (fasting blood glucose & GT; 10 mmol/L): insulin dosage exceeds 6 units/hour recently.

Design outcomes

Primary

MeasureTime frame
Infection rate within 30 days;

Secondary

MeasureTime frame
All adverse results within 30 days;Changes in nutritional indicators;Total length of hospital stay;

Countries

China

Contacts

Public ContactJing Changqing

Shandong First Medical University Affiliated Provincial Hospital

jing66510122@sina.com+86 15168888987

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026