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CompletedNCT03455296Updated Mar 19, 2021

Fluid Management Surgical Patients in Intensive Care Unit.

An interventional study of fluid therapy; crystalloid in Post Operative Fluid Management, sponsored by National Hepatology & Tropical Medicine Research Institute. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-19.

Sponsored by National Hepatology & Tropical Medicine Research Institute · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Post Operative Fluid Management
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

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.

    Also known as: Ringeror Ringer acetate or saline 0.9%

05

What researchers measure

Primary outcomes

  1. ICU stay

    Length of stay in days

    Time frame: 2-5 days

  2. medical complications

    notice any medical complications e.g.infections, pulmonary edema, pleural effusion, need mechanical ventilation, renal impairment

    Time frame: 2-5 days

  3. surgical complications

    notice any surgical complications e.g. wound dehisence, intrabdominal bleeding, ileus

    Time frame: 2-5 days

Secondary outcomes

  1. cost of each method

    cost for fluids given \& the method used ScVO2 or Lactate measurements

    Time frame: within 48 hours

  2. hospital stay

    length of stay

    Time frame: 2-5 days

  3. mortality

    28 day mortality

    Time frame: 28 day

06

Study locations

1 site
  • NHTMRI
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03455296
Lead sponsor
National Hepatology & Tropical Medicine Research Institute
Responsible party
ICU (Consultant of Intensive care medicine, Ph D, National Hepatology & Tropical Medicine Research Institute) — Principal investigator
First posted
Mar 6, 2018
Start date
Aug 1, 2018
Primary completion
Feb 15, 2020
Completion
May 15, 2020
Last update
Mar 19, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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