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A randomized, double-blind, parallel, controlled and multicenter study to assess the efficacy and safety of Compound Amino Acid(19) and Alanyl Glutamine Injection in postoperative patient with total parenteral nutrition(TPN)

A randomized, double-blind, parallel, controlled and multicenter study to assess the efficacy and safety of Compound Amino Acid(19) and Alanyl Glutamine Injection in postoperative patient with total parenteral nutrition(TPN)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15005920
Enrollment
Unknown
Registered
2015-01-06
Start date
2013-03-31
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Patients undergoing elective resection of stomach, small intestine and colon, who has indications for parenteral nutrition (PN) after operation.

Interventions

experimental group:10% Compound Amino Acid(19) and Alanyl Glutamine Injection
control group:8.5% Compound Amino Acid Injection(18AA-II)

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, weight 45-75kg; 2. Patients undergoing elective resection of stomach, small intestine and colon (including laparoscopic surgery), who has indications for parenteral nutrition (PN) after operation; 3. Nutritional risk screening (NRS 2002) grade equal and greater than 3; 4. Hb more than at least 80g/L, ALT, TBIL and DBIL levels are less than 1.5 times of the upper limit of normal. Serum creatinine is normal; 5. Patients without long-term fever, thyroid function hyperfunction, hypothyroidism or metabolic diseases such as diabetes, infectious diseases, mental illness; 6. Without radiation and chemotherapy therapy 3 weeks before operation; 7. Without PN 3 weeks before operation; 8. Understand and voluntarily endorse informed consent.

Exclusion criteria

Exclusion criteria: Subjects complying with any of the following exclusion criteria are not eligible to participate in this study: 1. The intraoperative bleeding >1000 ml, or intraoperative or postoperative supplementation of blood and/or blood products; 2. Serious organ damage, such as CHF (congestive heart-failure), patients with clinical symptoms of coronary artery disease and arrhythmia uncontrollable by existing medicines, etc.; 3. Past history of severe cerebrovascular disease; 4. Congenital abnormalities of amino acid metabolism or allergic to amino acids, fat emulsion, soybean etc.; 5. Participate in other clinical research at the same time; 6. Electrolyte imbalance before using experimental drug; 7. The patients that researchers do not consider fit for the trial; 8. Pregnancy or breast-feeding women.

Design outcomes

Primary

MeasureTime frame
Glutamine;Prealbumin;

Secondary

MeasureTime frame
Serum free amino acid profile;The ratio of lactulose to mannitol in urine(L/M ratio);

Countries

China

Contacts

Public ContactJianchun Yu
yu-jch@163.com+86 010 65296038

Outcome results

None listed

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