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Trial record 13 of 31 for:    shock | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

The Effect of Fluid Resuscitation With 0.9% Sodium Chloride Versus Balanced Crystalloid Solution on Renal Function of Sepsis Patients

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ClinicalTrials.gov Identifier: NCT03277677
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Nattachai Srisawat ,M.D., Chulalongkorn University

Tracking Information
First Submitted Date  ICMJE September 7, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
The incidence of acute kidney injury for any stage and severity [ Time Frame: at day 7 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03277677 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • The neutrophil function (chemotaxis, CD11b ) between two randomized groups at [ Time Frame: 0, 24, and 72 hours after resuscitation. ]
  • The monocyte function (HLA-DR) between two randomized groupsafter resuscitation. [ Time Frame: at 0, 24, and 72 hours after resuscitation. ]
  • The inflammatory marker (IL-6, IL-10) between two randomized groups at [ Time Frame: 0, 24, and 72 hours after resuscitation. ]
  • Urinary neutrophil gelatinase-associated lipocalin (NGAL) after randomization and after resuscitation with trial fluid [ Time Frame: at 0,24 and 72 hours after resuscitation. ]
  • Urinary liver-type fatty acid binding protein (L-FABP) [ Time Frame: at 0,24 and 72 hours after resuscitation. ]
  • Sequential [Sepsis-related] Organ Failure Assessment (SOFA) Score. (excluding Glasgow Coma Score) at 72 hours after randomization. [ Time Frame: at 72 hours after randomization. ]
  • Need of renal replacement therapy within 72 hours after randomization [ Time Frame: within 72 hours after randomization ]
  • Days alive without renal replacement therapy [ Time Frame: in 28 days after randomization ]
  • Hospital length of stay for survivors sanctioned [ Time Frame: at 28 days after randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Fluid Resuscitation With 0.9% Sodium Chloride Versus Balanced Crystalloid Solution on Renal Function of Sepsis Patients
Official Title  ICMJE The Effect of Fluid Resuscitation With 0.9% Sodium Chloride Versus Balanced Crystalloid Solution on Renal Function of Sepsis Patients
Brief Summary

The high chloride content of 0.9%sodium chloride (0.9%NaCl) leads to adverse pathophysiological effects in both animals and healthy human volunteers. Small randomized trials confirm that the hyperchloremic acidosis induced by 0.9%NaCl also occurs in patients. A strong signal is emerging from recent large propensity-matched and cohort studies for the adverse effects that 0.9% NaCl has on the clinical outcome in surgical and critically ill patients when compared with balanced crystalloids. Major complications are the increased incidences of acute kidney injury and the need for renal replacement therapy, and that pathological hyperchloremia may increase postoperative mortality.

Fluid resuscitation with 0.9% NaCl in animals with sepsis resulted in hyperchloremic metabolic acidosis, worsened AKI, and increased mortality when compared with resuscitation with a balanced crystalloid solution.

Furthermore, hyperchloremic acidosis also resulted in increased concentrations of circulating inflammatory mediators in an experimental model of severe sepsis in rats, with a dose-dependent increase in circulating interleukin-6, tumor necrosis factor-a, and interleukin-10 concentrations with increasing acidosis.

Thus, in this study, investigators compared the effects of a balanced crystalloid solution with 0.9% NaCl on the renal function in severe sepsis/septic shock patients. Investigators hypothesized that balanced crystalloid solution resuscitation would decrease AKI incidence and severity and would improve immunomodulatory effect when compared with 0.9% NaCl resuscitation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sepsis
  • Septic Shock
  • Acute Kidney Injury
Intervention  ICMJE
  • Drug: Normal saline
    for resuscitation in sepsis patients
  • Drug: Ringer's Acetate
    for resuscitation in sepsis patients
Study Arms  ICMJE
  • Active Comparator: normal saline
    Intervention: Drug: Normal saline
  • Active Comparator: balanced solution
    Intervention: Drug: Ringer's Acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2017)
236
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years old
  • Who need fluid resuscitation in the Emergency Room (ER).
  • Who have fulfilled the criteria for sepsis/septic shock within the previous 24 hours according to sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.

    o Patients with infection and resulted from a host's systemic inflammatory response syndrome (SIRS) to infection are defined as sepsis if meet the criteria 2 or more of

    • Temperature >38°C or <36°C
    • Heart rate >90/min
    • Respiratory rate >20/min or PaCo2 <32 mm Hg (4.3 kPa)
    • White blood cell count >12000/mm3 or <4000/mm3 or >10% immature bands.
  • Patient who have Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.

    o Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.

  • AND where informed consent is obtainable either from the patient or by proxy (first degree relative, spouse) if patients aren't in fully conscious status (eg.comatose, drowsiness, irritable).

Exclusion criteria

Exclusion Criteria:

  • Patients with chronic kidney disease (CKD) defined by baseline serum creatinine > 2.0 in male and 1.5 in female.
  • Patients with End stage renal disease (ESRD) with or without renal replacement therapy.
  • Patients with active cardiac disease : severe valvular heart, cardiomyopathy, decompensated heart failure NYHA II-IV, severe pulmonary hypertension.
  • HIV/AIDs Patients.
  • Allergy towards 0.9% NaCl or Ringer's Acetate.
  • Any form of renal replacement therapy.
  • Intracranial bleeding within current hospitalization.
  • Therapy with corticosteroid or non steroidal anti-inflammatory substance.
  • Patients who predicted not to survive more than 24 hours.
  • Pregnant and lactating patients.
  • Withdrawal of active therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nattachai Srisawat, MD 6622564000 ext 3597 drnattachai@yahoo.com
Contact: Sasithorn Kunupakan, MD 66831999741 nonghui2010@gmail.com
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03277677
Other Study ID Numbers  ICMJE 113/60
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nattachai Srisawat ,M.D., Chulalongkorn University
Study Sponsor  ICMJE Chulalongkorn University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chulalongkorn University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP