Fluid Management Surgical Patients in Intensive Care Unit.
Condition: Post Operative Fluid Management
Study type: Interventional

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.
    

Intervention name(s): fluid therapy; crystalloid
Intervention type(s): Other
Intervention description(s): maintenance fluid e.g. Ringer or Ringer acetate plus replacement fluid with crystalloids e.g. Ringer,or Ringer acetate or saline 0.9%, 500ml / 30 min. guided by ScVO2 with 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. Maintenance fluid without replacement will be initiated if ScVO2 or lactate value normalized.
Other intervention name(s): Ringeror Ringer acetate or saline 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care