High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis

NCT ID: NCT03530046

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-01-18

Brief Summary

This is a research to study primarily the effect of rapidly infused high strong ion difference (SID) fluid vs Hartmann's solution in altering the pH and bicarbonate level of the patient, who is in sepsis with metabolic acidosis. Half of the study population gets high SID fluid, while the other half will get Hartmann's solution.

Detailed Description

Balanced fluids are preferred in initial resuscitation of septic patients based on several recent studies.

The Stewart's concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level.

High SID fluid are specially formulated by adding sodium bicarbonate into half saline solution, the resultant fluid contains sodium= 145mmol/L and chloride=70mmol/L (SID= 75) as compared to Hartmann's solution with the SID of 20.

Conditions

Septicemic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

High SID fluid

Group 1: half-normal saline with addition of 75mEq/L sodium bicarbonate

Group Type: EXPERIMENTAL

High SID fluid

Intervention Type: COMBINATION_PRODUCT

The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.

Hartmann's solution

Group 2: Hartmann's Solution

Group Type: ACTIVE_COMPARATOR

Hartmann's solution

Intervention Type: COMBINATION_PRODUCT

The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.

Interventions

High SID fluid

The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.

Intervention Type: COMBINATION_PRODUCT

Hartmann's solution

The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• age≥18 years
• fulfills 2/3 qSOFA criteria
• presumed infection
• a blood pH at presentation ≤ 7.35
• hyperlactatemia (blood lactate level, >2mmol/L )

Exclusion Criteria

• existing cardiac failure, major cardiac arrhythmia, advanced chronic kidney disease or end stage failure
• known pregnancy
• suspected dengue
• primary diagnosis is related to burn, trauma, or drug overdose
• if more than 500cc of resuscitation fluid was administered before enrollment.

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

Sponsors

Clinical Research Centre, Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Yeoh Chun Chiat

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chunchiat Yeoh, MD

Role: PRINCIPAL_INVESTIGATOR

Emergency Department, Hospital Pulau Pinang

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ED-HPP-1701

Identifier Type: -

Identifier Source: org_study_id