Fluid Resuscitation in Burn Patients

Fluid Resuscitation Clinical Trial

— CARE  

Official title:

Clearance of Acetate During Fluid Resuscitation of Critically Ill Burn Patients: The CARE Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118362
• Other study ID #: P160502
• Status: Completed
• Phase: Phase 3
• Start date: August 9, 2017
• Est. completion date: December 2, 2019

Study information

• Verified date: December 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Balanced solutions with low chloride concentration could represent an alternative to high chloride concentration solutions. Such balanced solutions contain other acid as buffers (i.e. acetate and/or gluconate). However, acetate has been associated with alteration of cardiac function when used as buffer in dialysate when high acetate concentrations are used and could promote the development of metabolic acidosis if it accumulates. Therefore, the safety of such solutions remains poorly explored. Because critically ill patients receive large amount of fluid during the early phase of resuscitation, large amount of acetate are to be administrated if such solutions are used. While acetate-containing solutions have been suggested to be safe in this setting, studies are still lacking regarding clearance and accumulation in critically ill patients.

It is expected to include 28 patients, the objective to analyze the data of 20 patients.

Description:

The main objectives of the study is 1) to determine whether Plasmalyte® promote the development of metabolic acidosis in comparison with an acetate-free balanced solutions: Ringer lactate (chloride concentration of 111 mmol/L) and 2) to determine Acetate & gluconate clearance during fluid resuscitation of severely burn patients Plasmalyte® (chloride concentration of 98 mmol/L) . Severely burn patients will be randomized to receive Plasmalyte® or Ringer Lactate for initial fluid resuscitation during the first 5 days following admission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2, 2019
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients over 18 years

• TBSA>30%

• Admission to an intensive care unit within 12 hours after burn injury

• Signed informed consent to Patient / Parent / ( Inclusion in Emergency and Consent is Collected)

• social Insurance cover

Exclusion Criteria:

• Decline to participate

• pregnancy

• Metabolic alkalosis (excess of base> 5mmol / L)

• legal obstacle to participate

Related Conditions & MeSH terms

• Burns
• Fluid Resuscitation
• Severe Burns

Intervention

Drug:
• Plasmalyte
Parenteral administration of Plasmalyte initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring. Each patient will receive this solution up to 5 days.
• Ringer lactate
Parenteral administration of Ringer lactate initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring. Each patient will receive this solution up to 5 days.

Locations

Country	Name	City	State
France	Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

Davies PG, Venkatesh B, Morgan TJ, Presneill JJ, Kruger PS, Thomas BJ, Roberts MS, Mundy J. Plasma acetate, gluconate and interleukin-6 profiles during and after cardiopulmonary bypass: a comparison of Plasma-Lyte 148 with a bicarbonate-balanced solution. Crit Care. 2011;15(1):R21. doi: 10.1186/cc9966. Epub 2011 Jan 14. — View Citation

Hahn RG. Should anaesthetists stop infusing isotonic saline? Br J Anaesth. 2014 Jan;112(1):4-6. doi: 10.1093/bja/aet292. — View Citation

Morgan TJ, Power G, Venkatesh B, Jones MA. Acid-base effects of a bicarbonate-balanced priming fluid during cardiopulmonary bypass: comparison with Plasma-Lyte 148. A randomised single-blinded study. Anaesth Intensive Care. 2008 Nov;36(6):822-9. Erratum in: Anaesth Intensive Care. 2012 Jul;40(4):719. — View Citation

Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5. — View Citation

Zhou F, Peng ZY, Bishop JV, Cove ME, Singbartl K, Kellum JA. Effects of fluid resuscitation with 0.9% saline versus a balanced electrolyte solution on acute kidney injury in a rat model of sepsis*. Crit Care Med. 2014 Apr;42(4):e270-8. doi: 10.1097/CCM.0000000000000145. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission.	Arterial blood gas analysis	after 24 hours of admission.
Secondary	Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate.	Arterial blood gas analysis	Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.
Secondary	acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion	Arterial blood gas analysis	Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.
Secondary	Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%)	Trans-thoracic or trans-esophageal ultrasound	Every day during 5 days
Secondary	Incidence of AKI (according to the KDIGO definition)	urine output and serum creatinine	Every day during 5 days
Secondary	Sequential Organ Failure Assessment score	SOFA score calculation	During the first 5 days of intensive care unit stay
Secondary	mortality at day 28	Mortality will be collected	At 28 day after admission