Clinical trial NCT03455296: Fluid Management Surgical Patients in Intensive Care Unit.
Official title: Fluid Management Guided With Lactate Clearance Versus Central Venous Oxygen Saturation Monitoring in Surgical Patients in Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Fluid Management
Lead sponsor: National Hepatology & Tropical Medicine Research Institute
Sponsor class: OTHER_GOV
First posted: 2018-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the efficacy of lactate clearance (LCR) versus central venous oxygen saturation (ScVO2) to guide fluid management for post-operative patients in the intensive care unit (ICU).

Detailed description: Sixty patients will be randomly assigned in a 1:1 manner into two groups; (group A= thirty patients = ScVO2) \& (group B = thirty patients =lactate clearance). Fluid therapy will be initiated in each group with maintenance in the form of crystalloid e.g. Ringer or Ringer acetate (in a dose of 30-35 ml/Kg/day) plus replacement with crystalloid e.g. Ringer, Ringer acetate or saline 0.9%, 500 ml over 10-30 min. that will be administered in boluses \[7\] guided by ScVO2with target value ≥ 70% versus lactate clearance (LCR) with target value ≤ 2mmol/L (or decline ≥ 10%) by the end of the study in group A \& group B respectively with close regular clinical monitoring/30min., CVP limits 12-16 cmH2O \& mean arterial pressure (MAP) 65-90mmHg. Maintenance fluid without replacement will be initiated alone if ScVO2 or lactate value normalized or are normal from the start.

All demographic data will be obtained including the patients' age, sex, body mass index (BMI), associated co-morbidities (diabetes mellitus \&hypertension), Sequential Organ Failure Assessment (SOFA) on admission \& discharge from ICU, duration of surgery, the type of surgery, the amount of blood loss intraoperative, the amount of blood transfused intraoperative, the need\&the amount of blood transfusion postoperative \& will be recorded.

Follow-up hemodynamics including the heart rate, mean arterial pressure (MAP), CVP, arterial oxygen saturation (SaO2), urine volume, fluid balance, blood gases (base excess, PH), hypoxic index (PaO2/FIO2 ratio) \& total fluid infused as a baseline then followed as required. Monitoring of either lactate level or ScVO2 on admission followed and recorded at regular intervals during treatment on 0, 2, 6, 12, 24 \& 48hours.

Laboratory investigations including the complete blood profile, prothrombin time, liver functions, serum creatinine \& serum electrolytes will be assessed at randomization as a baseline \& then will be recorded as required. Postoperative medical or surgical morbidities will be followed during ICU \& hospital stay e.g. weight gain, impairment of hypoxic index (P/F ratio), pulmonary edema, pleural effusion, need for mechanical ventilation, paralytic ileus, renal impairment\& intra-abdominal bleeding.28-day mortality will be asked for \& followed by calling the telephone number of the patient or one of his/her first-degree relatives.

Eligibility criteria: Inclusion Criteria:

* Patients who are admitted to the intensive care unit of National Hepatology \& Tropical Medicine Research Institute (NHTMRI) post intra-abdominal surgical intervention.

Exclusion Criteria:

* Patients will be excluded from the study if they have severe liver impairment (child-Pugh C15), septic shock or hemodynamic instability requiring high dose circulatory support e.g. \> 2ug/min noradrenaline as it will impair lactate clearance \&/or central venous oxygen saturation normalization, advanced heart failure, central venous pressure (CVP) ≥ 18cmH2O as it will limit fluid therapy, severe hypothermia (\< 28◦ C) as it will induce lactate production.

Primary outcomes:
measure: ICU stay
timeFrame: 2-5 days
measure: medical complications
timeFrame: 2-5 days
measure: surgical complications
timeFrame: 2-5 days
Secondary outcomes:
measure: cost of each method
timeFrame: within 48 hours
measure: hospital stay
timeFrame: 2-5 days
measure: mortality
timeFrame: 28 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NHTMRI
Study officials:
References: