Sodium Bicarbonate Ringer's Solution Versus Normal Saline for Early Fluid Resuscitation in Patients With Sepsis

At present, people still have different opinions on choosing which kind of crystalloid solution for patients with sepsis, and there is no unified standard yet. It is necessary to conduct systematic studies on comparison of different fluid resuscitation methods on the efficacy and safety of crystalloid solution for patients with sepsis. Therefore, this study focuses on the efficacy and safety of sodium bicarbonate Ringer's solution compared with normal saline.

Study Overview

• Status: Recruiting
• Conditions: Sepsis, Septic Shock
• Intervention / Treatment: Drug: Sodium Bicarbonate Ringer's Solution; Drug: Normal Saline

Detailed Description

Sepsis and septic shock are clinical emergencies requiring immediate treatment and fluid resuscitation. Early effective fluid resuscitation can improve the prognosis of patients. So far, there is no perfect crystalloid solution. Normal saline is the most readily available and economical crystalline fluid for clinical resuscitation. It is isoosmotic and can meet the basic needs of patients in the early rehydration. But it lacks acid-base buffer system and potassium, calcium and magnesium ions, and the level of chloride ions is also significantly higher than that of plasma.

Sodium Bicarbonate Ringer's solution contains physiological levels of Na+(130mmol/L), K+(4mmol/L), Ca2+(1.5mmol/L), Mg2+(1mmol/L), HCO3-(28mmol/L) and Cl-(109mmol/L). It also has citric acid/ sodium citrate buffer system (Citrate3-1.3mmol/L), pH7.3, and osmotic pressure 276mOsm/L. It is the most similar solution to extracellular fluid.

Theoretically，Compared with normal saline, Sodium Bicarbonate Ringer's solution can maintain acid-base balance faster and better when restoring the microcirculation without affecting the level of chloride ion. Therefore we hypothesize that Sodium Bicarbonate Ringer's solution can promote the body to restore to acid-base balance more quickly, and improve organ function more significantly than normal saline.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Zhang; Phone Number: +8615874875763; Email: zln7095@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
      • Contact: Lina Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed as sepsis or septic shock according to the definition of Sepsis-3.0 with fluid resuscitation requirement;
• aged between 18 and 80, male or female;
• Signed informed Consent (with delay within 24 hours).

Exclusion Criteria:

• Patients with hypermagnesemia;
• Patients with hypothyroidism;
• Patients predicted to die or discharged within 24 hours after admission;
• Patients with previous history of mental illness, severe hepatic and renal insufficiency, severe cardiac disease, primary severe central nervous system lesions;
• Pregnant or breast-feeding women;
• Patients who have received cardiopulmonary resuscitation；
• Patients who participated in other clinical trials within 30 days;
• Patients have other conditions that are not appropriate for inclusion according to the researcher's judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium Bicarbonate Ringer's Solution; Intravenous drip, 500~1000ml per time. Infusion speed: 15ml/kg/h or according to guidelines or department routine.	Drug: Sodium Bicarbonate Ringer's Solution; This group was treated with Sodium Bicarbonate Ringer's Solution.; Other Names: Bicarbonated Ringer's solution
Active Comparator: Normal Saline; Intravenous drip, 500~1000ml per time. Dosage depends on age、weight and symptoms. Infusion speed: According to the department process or clinician's decision.	Drug: Normal Saline; This group was treated with normal saline.; Other Names: physiological saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sequential Organ Failure Assessment(SOFA) value at 24h	ΔSOFA=SOFA24h-SOFA0h	0 hours, 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum lactate clearance rate	(Serum lactete0h-serum lactate6h)/serum lactate0h	0 hours, 6 hours
The proportion of patients with serum lactate clearance rate>30%	the proportion of patients whose serum lactate decrease by more than 30%	0 hours, 6 hours, 24 hours
Changes in pH value over time, and the lowest pH value during hospitalization	ΔpH=pH3h/6h/24h-pH0h, and the lowest pH value during hospitalization	0 hours, 3 hours, 6 hours, 24 hours
Changes in base residue (BE value) over time	ΔBE=BE3h/6h/24h-BE0h	0 hours, 3 hours, 6 hours, 24 hours
Changes in serum bicarbonate(HCO3-) over time	ΔHCO3-=HCO3-3h/6h/24h-HCO3-0h	0 hours, 3 hours, 6 hours, 24 hours
The proportion of patients with hyperchloremia	The proportion of patients with hyperchloremia at 3h and 24h.	0 hours, 3 hours, 24 hours
Changes in SOFA score over time	ΔSOFA=SOFA24h/48h/72h-SOFA0h	0 hours, 24 hours, 48 hours, 72 hours
Changes in APACHEII score over time	ΔAPACHEII=APACHEII24h/48h/72h-APACHEII0h	0 hours, 24 hours, 48 hours, 72 hours
Mechanical ventilation time(h)	the length of mechanical ventilation time within 7 days	Within 7 days
The proportion of patients receiving RRT	The proportion of patients receiving RRT within 7 days	Within 7 days

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Lina Zhang, Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Fluid Resuscitation, Crystalloid Solution
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Pharmaceutical Solutions
• Other Study ID Numbers: RIN005-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No