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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03118362
Other study ID # P160502
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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