Safety and Efficacy of Sodium Bicarbonate Ringer Injection

NCT04596956 | Unknown Phase 4

• 1 other identifier: 2020MZ01
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives

1. 1.To observe whether sodium bicarbonate Ringer injections can reduce the incidence of postoperative complications in elderly patients undergoing abdominal surgery.
2. 2.To observe the effects of sodium bicarbonate Ringer injections on the internal environment, such as water, electrolytes, acid-base balance, and other physiological indexes, in the perioperative period of elderly patients undergoing abdominal surgery.
3. 3.Elderly abdominal surgery patients who meet the inclusion criteria will be enrolled and randomly divided into two groups according to the intraoperative application of extracellular fluid supplements. The experimental group is sodium bicarbonate Ringer injection group, and the control group is sodium lactate Ringer injection. Basic preoperative information of patients will be collected. The vital signs, fluid treatment, and surgical anaesthesia will be recorded during the operation, while the recovery and postoperative complications will be recorded during postoperative visits.
4. 4.The ability of sodium bicarbonate Ringer injections to reduce postoperative complications in elderly patients undergoing abdominal surgery will be observed.
5. 5.The effects of sodium bicarbonate Ringer injection on the internal environment, such as water, electrolytes, acid-base balance, and other physiological indexes in elderly patients undergoing abdominal surgery will be observed and compared.
6. 6.The safety and efficacy of sodium bicarbonate Ringer injection in elderly patients with abdominal diseases will be comprehensively assessed.

Conditions

Ringer Bicarbonate; Elderly Abdominal Surgery; Safety; Effectiveness

Outcome Measures

Primary Outcomes (1)

• Complication rate (including death)

  Complications include: bleeding, infection (incision infection, blood infection, urinary system infection), gastrointestinal complications (postoperative intestinal obstruction, anastomotic leakage), pulmonary complications (pulmonary infection, pulmonary embolism) ), cardiovascular complications (cardiac arrest, arrhythmia, heart failure, myocardial infarction), neurological complications (delirium, stroke), urinary system complications (renal insufficiency), etc. (refer to International Surgical Prognosis Study, ISOS ), and died during hospitalization.

  30days

Study Arms (2)

sodium bicarbonate Ringer injection

EXPERIMENTAL

Drug: sodium bicarbonate Ringer injection

Ringer lactate solution

ACTIVE COMPARATOR

Drug: Lactated Ringer's solution

Interventions

sodium bicarbonate Ringer injection DRUG

Used in surgery

sodium bicarbonate Ringer injection

Lactated Ringer's solution DRUG

Used in surgery

Ringer lactate solution

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Wenzhu Shi

CONTACT

+86-15110199887; shiwenzhu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Anesthesia

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 22, 2020
• Study Start: October 1, 2020
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 22, 2020

Record last verified: 2020-10