Safety and Efficacy of Sodium Bicarbonate Ringer Injection

Launched by CHINESE PLA GENERAL HOSPITAL · Oct 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of sodium bicarbonate Ringer injections to see if they can help reduce complications after abdominal surgery in elderly patients. Researchers want to find out if these injections can improve the balance of fluids and electrolytes in the body, which is important for recovery after surgery. The trial will include 5,000 elderly patients, all over the age of 65, who are scheduled for upper abdominal surgery lasting more than two hours. Participants will be randomly placed into two groups: one will receive sodium bicarbonate Ringer injections, while the other will receive a different type of fluid called lactated Ringer's.

If you or a loved one is considering participating in this trial, you should know that it involves monitoring during surgery and follow-up checks after surgery to track recovery and any complications. Participants will be required to provide informed consent, meaning they agree to take part in the study after understanding its purpose and procedures. This trial is not yet recruiting, but it aims to provide valuable information on the safety and effectiveness of sodium bicarbonate Ringer injections for elderly patients undergoing surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1) Patients need to be over 65 years of age, while there is no restriction on gender.
• • (2) Patients are planned to undergo upper abdominal surgery under general anaesthesia, with an expected operation time of \>2 h, and the infusion volume is \>1000ml.
• • (3) The patient agrees to participate in the clinical research and signs the informed consent.
• Exclusion Criteria:
• • (1) Emergency surgery
• • (2) Hypermagnesemia (defined as serum Mg2+ \>1.25mmol/L)
• • (3) Patients who participated in other drug trials in the past 6 months
• • (4) Known allergic reactions to the test drug and/or its components
• • (5) Patients judged to lack the ability of providing informed consent
• • (6) Other situations considered unsuitable for enrollment by the researcher.