Bicarbonated Ringer's Solution Versus Lactated Ringer's Solution in Patients With Septic Shock

NCT ID: NCT04449757

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-05-30

Brief Summary

In this prospective randomized controlled trial, investigators aim to study the effects and safety of bicarbonated Ringer's solution in patients with septic shock compared with lactated ringer's solution, and provide evidence for current fluid resuscitation strategies for septic shock.

Detailed Description

Although the latest guidelines recommend crystalloids as the first choice for the patients' fluid resuscitation, it still remains controversial that which crystalloid solution is the best choice. It is reported that balanced crystalloid can result in better outcomes than saline for critically ill patients. However, there are few studies conducted between different crystalloid solutions.

Lactated ringer's solution is the longest-used crystalloid solution. Compared with lactated ringer's solution whose anion is lactate, the anion of bicarbonate ringer's solution is bicarbonate. And lactate needs to be metabolized into bicarbonate through the mitochondria of the liver before it can play an alkalization role. Therefore, in theory, bicarbonate ringer's solution does not need to rely on liver metabolism, the onset time to maintain acid-base balance is shorter, and it may be more suitable for patients with severe acidosis. In patients with septic shock, the incidence of moderate to severe metabolic is increased. Bicarbonate ringer's solution can directly supplement the concentration of bicarbonate, while lactated ringer's solution needs to take time and be metabolized in the liver. Thus, we hypothesize that bicarbonate ringer's solution is more effective for patients with shock and metabolic acidosis than lactated ringer's solution.

Conditions

Septic Shock; Fluid Resuscitation; Crystalloid Solution; Intensive Care Unit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bicarbonated ringer's solution

We apply bicarbonated ringer's solution as resuscitation fluid to patients with septic shock.

Group Type: EXPERIMENTAL

Bicarbonated Ringer's solution

Intervention Type: DRUG

Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.

lactated ringer's solution

We apply lactated ringer's solution as resuscitation fluid to patients with septic shock.

Group Type: EXPERIMENTAL

Lactated Ringer's solution

Intervention Type: DRUG

Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.

Interventions

Bicarbonated Ringer's solution

Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.

Intervention Type: DRUG

Lactated Ringer's solution

Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.

Intervention Type: DRUG

Other Intervention Names

Ringers Bicarbonate; Ringers Lactate

Eligibility Criteria

Inclusion Criteria

• 1. At the age of 18 to 75;
• 2. Being treated in the ICU;
• 3. Diagnosed as septic shock according tho the definition of Sepsis 3.0 with fluid resuscitation requirement.

Exclusion Criteria

• 1. Severe hepatic failure;
• 2. Possible brain injury;
• 3. With absolute contraindications for central vena catheterization;
• 4. Ever participated in another clinical trial within 30 days prior enrollment;
• 5. Have corrected metabolic acidosis through alkaline drug application within 24 hours prior to enrollment;
• 6. Hypermagnesemia or hypothyroidism;
• 7. Pregnant of breast-feeding women;
• 8. Considered inevitable death;
• 9. Other situations where investigators think enrollment is not appropriate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

ZhiYong Peng

Professor; Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

2020044

Identifier Type: -

Identifier Source: org_study_id