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NCT Number: NCT03530046

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

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.

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Key information

Conditions

Septicemic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High SID fluid

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

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.

Primary outcomes

  1. pH change

    Time frame: 2 hours

  2. bicarbonate level change

    Time frame: 2 hours

    mmol/L

Secondary outcomes

  1. Lactate level difference

    Time frame: 2 hours

    percentage

  2. Development of pulmonary edema

    Time frame: 48 hours

  3. 30 days all-cause mortality

    Time frame: 30 days

  4. Length of stay

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Clinical Research Centre, Malaysia

Other

Registry information

Official study title

A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference Fluid Versus Hartmann's Solution on Acid-Base Status in Sepsis and Septic Shock Patients in the Emergency Department Hospital Pulau Pinang

Acronym: HiSIDSS

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 21, 2018
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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