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Fluid Management Surgical Patients in Intensive Care Unit.

Fluid Management Guided With Lactate Clearance Versus Central Venous Oxygen Saturation Monitoring in Surgical Patients in Intensive Care Unit.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03455296
Enrollment
60
Registered
2018-03-06
Start date
2018-08-01
Completion date
2020-05-15
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Fluid Management

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.

Interventions

OTHERfluid 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.

Sponsors

National Hepatology & Tropical Medicine Research Institute
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ICU stay2-5 daysLength of stay in days
medical complications2-5 daysnotice any medical complications e.g.infections, pulmonary edema, pleural effusion, need mechanical ventilation, renal impairment
surgical complications2-5 daysnotice any surgical complications e.g. wound dehisence, intrabdominal bleeding, ileus

Secondary

MeasureTime frameDescription
cost of each methodwithin 48 hourscost for fluids given & the method used ScVO2 or Lactate measurements
hospital stay2-5 dayslength of stay
mortality28 day28 day mortality

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026