Fluid Management Surgical Patients in Intensive Care Unit.

• ClinicalTrials.gov Identifier: NCT03455296
• Recruitment Status: Completed
• First Posted: March 6, 2018
• Last Update Posted: March 19, 2021
• Sponsor: National Hepatology & Tropical Medicine Research Institute
• Information provided by (Responsible Party): ICU, National Hepatology & Tropical Medicine Research Institute

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Post Operative Fluid Management	Other: fluid therapy; crystalloid	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Fluid Management Guided With Lactate Clearance Versus Central Venous Oxygen Saturation Monitoring in Surgical Patients in Intensive Care Unit.
• Actual Study Start Date: August 1, 2018
• Actual Primary Completion Date: February 15, 2020
• Actual Study Completion Date: May 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: central venous oxygen saturation ScVO2 normalization; Fluid therapy is initiated with maintenance fluid (Ringer or Ringer acetate) plus replacement with crystalloids (Ringer, Ringer acetate or saline 0.9%) 500ml / 30 min. guided by ScVO2with target value ≥ 70%	Other: fluid therapy; crystalloid; 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 Name: Ringeror Ringer acetate or saline 0.9%
Active Comparator: Lactate clearance; Fluid therapy is initiated with maintenance fluid (Ringer or Ringer acetate) plus replacement with crystalloids 500ml / 30 min. guided by lactate clearance (LCR) with target value ≤ 2mmol/L (or decline ≥ 10%) by the end of the study	Other: fluid therapy; crystalloid; 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 Name: Ringeror Ringer acetate or saline 0.9%

Outcome Measures

Primary Outcome Measures :

1. ICU stay [ Time Frame: 2-5 days ]
   Length of stay in days
2. medical complications [ Time Frame: 2-5 days ]
   notice any medical complications e.g.infections, pulmonary edema, pleural effusion, need mechanical ventilation, renal impairment
3. surgical complications [ Time Frame: 2-5 days ]
   notice any surgical complications e.g. wound dehisence, intrabdominal bleeding, ileus

Secondary Outcome Measures :

1. cost of each method [ Time Frame: within 48 hours ]
   cost for fluids given & the method used ScVO2 or Lactate measurements
2. hospital stay [ Time Frame: 2-5 days ]
   length of stay
3. mortality [ Time Frame: 28 day ]
   28 day mortality

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Egypt

NHTMRI

Cairo, Egypt

Sponsors and Collaborators

National Hepatology & Tropical Medicine Research Institute

More Information

• Responsible Party: ICU, Consultant of Intensive care medicine, Ph D, National Hepatology & Tropical Medicine Research Institute
• ClinicalTrials.gov Identifier: NCT03455296
• Other Study ID Numbers: Lactate
• First Posted: March 6, 2018
• Last Update Posted: March 19, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No