Ringer's Lactate Clinical Trial
Official title:
Common Clinical Indices-guided Bolus-based vs. Continuous Fluid Management A Prospective, Randomized Trial
Fluid therapy is a cornerstone in patient therapy perioperatively. Many studies have
addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies
focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more
common subject of research was- the correct evaluation of the dynamic fluid status of
patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic
therapy (GDHT) trials and has become a widely used approach in intraoperative fluid
management.
While there are numerous studies on the intraoperative outcome of GDHT, research on the
immediate postoperative outcome of GDHT therapy use is scarce.
In this study the investigators aim to evaluate the efficacy of bolus-based fluid management
guided by common clinical parameters in postoperative period in post-anesthesia care unit.
In this randomized clinical trial all patients will be randomized to one of the following
groups:
The control group will receive standard care which includes fluid maintenance program as
dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.
The GDT group will not receive any maintenance fluid. Fluid boluses will be given according
to the flowchart attached.
Measurements of hemodynamic variables including heart rate and automatic non-invasive blood
pressure measurements as well pulse oximetry as routine procedures will be recorded and
stored by Metavision system (iMDsoft company) at regular intervals, all according to standard
clinical practice.
Blood gases measurement will be performed upon admission and at discharge. Urine output will
be measured and recorded every hour.
Methods Prior to surgery the patient will be assessed in the pre-anesthesia clinic, study
protocol will be explained, questions answered and informed consent form will be signed by
one of the investigating physicians. In case of an urgent case with no pre-anesthetic clinic
visit, the process will take place in the entrance to the surgery room. Following surgery,
patients will be assessed for eligibility and randomized to one of the study arms.
The control group will receive standard care which includes fluid maintenance program as
dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.
Study Arm:
The GDT group will not receive any maintenance fluid. Fluid boluses will be given according
to the flowchart attached.
Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be
recorded according to community medical record.
Blood products will be administered according to departmental guidelines and clinician
decision unrelated to participation in the study.
Patients will be extubated, either in the operating room or postoperatively, when they
fulfilled standard clinical criteria (adequate protective reflexes, adequate oxygenation, and
stable hemodynamics), according to clinical indication unrelated to the participation in the
study.
Measurements of hemodynamic variables including heart rate and automatic non-invasive blood
pressure measurements as well pulse oximetry as routine procedures will be recorded and
stored by Metavision system (iMDsoft company) at regular intervals, all according to standard
clinical practice.
Blood gases measurement will be performed upon admission and at discharge. Urine output will
be measured and recorded every hour.
Other laboratory exams will be taken based on the physician discretion unrelated to the
participation in the study.
Data Collection:
For each participating patient the following data will be collected and recorded:
1. Demographic data
2. Medical history including regular medications
3. Hemodynamic data including heart rate, automatic non-invasive blood pressure
measurements, temperature as well pulse oximetry as routine procedures will be recorded
and stored by Metavision system
4. Anesthetic data including anesthetic method, anesthetic drugs, total fluid intake,
anesthetic complications.
5. Laboratory values
6. Length of stay in PACU
7. Length of stay in hospital
8. Post-operative pulmonary complications
9. Acute kidney injury
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05777135 -
Ringer Lactate Preloading on Induction Dose Requirement of Propofol
|
Phase 4 |