ActivePhase 4ACTRN12614000269639

A single centre nested cohort study investigating the effect of using 0.9 % saline or Plasmalyte 148 as primary fluid therapy on gastrointestinal complications in mechanically ventilated patients with nasogastric enteral nutrition

Sponsor

Medical Research Institute of New Zealand

Enrollment

200 participants

Start Date

Apr 5, 2014

Study Type

Interventional

Conditions

Mechanical Ventilation Critical Illness

Summary

0.9% saline has been used in clinical practice for fluid resuscitation and general fluid therapy since the 1880s. While it is the most commonly used IV resuscitation fluid in the world, some data raise the possibility that using 0.9% saline for intravenous therapy may be related to altered gastrointestinal (GI) function .Current data are insufficient to recommend clinical practice change and further data from an interventional trial are urgently needed. However, the design of such a Trial requires sufficient pilot data to establish feasibility, safety, power calculations, and define an optimal study protocol.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

Adult patients > 18 years.
Patients who are expected to be mechanically ventilated for greater than 48 hours and receiving NG enteral nutrition.

Exclusion Criteria8

Patients who are <18 years in age.
Patients expected to require mechanical ventilation for less than 48 hours.
Patients mechanically ventilated and not receiving enteral nutrition.
Patients receiving duodenal or jejunal feeding.
Patients who are expected to require renal replacement therapy within six hours of ICU admission.
Patients who are usually on dialysis for end stage renal failure.
Patients who are admitted to the ICU solely for consideration of organ donation or for palliative care.
Patients previously enrolled in the SPLIT trial.

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Interventions

This study is conducted as a single centre nested cohort study within the SPLIT study (0.9 % Saline versus Plasma-Lyte (Registered Trademark) 148 for Intensive Care Fluid Therapy). Intervention =

This study is conducted as a single centre nested cohort study within the SPLIT study (0.9 % Saline versus Plasma-Lyte (Registered Trademark) 148 for Intensive Care Fluid Therapy). Intervention = Plasma-Lyte (Registered Trademark) 148, this will be given at intravenously at the discretion of the treating clinician during the ICU stay. Fluid will be given in alternating seven week blocks. Any patient who remains in the ICU after a crossover period will continue to receive the study fluid to which they were originally assigned up to 90 days after enrolment. As a result, no washout is required between cross-over periods. The treatments will be administered ‘blind’ to both investigators and patients. Patients enrolled into the SPLIT study, expected to be mechanically ventilated for longer than 48 hours, and receiving enteral nutrition via nasogastric tube will be eligible for this pilot study. During the study period the intensive care unit will be randomly assigned to a 7 week period of administration of trial fluid. There is a double crossover approach so that the each strategy is given twice.