Fluid Management Surgical Patients in Intensive Care Unit.

NCT03455296 | Completed

• 1 other identifier: Lactate
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Operative Fluid Management

Outcome Measures

Primary Outcomes (3)

• ICU stay

  Length of stay in days

  2-5 days

• medical complications

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

  2-5 days

• surgical complications

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

  2-5 days

Secondary Outcomes (3)

• cost of each method

  within 48 hours

• hospital stay

  2-5 days

• mortality

  28 day

Study Arms (2)

central venous oxygen saturation ScVO2 normalization

ACTIVE COMPARATOR

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

Lactate clearance

ACTIVE COMPARATOR

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

fluid therapy; crystalloid OTHER

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%

Lactate clearance; central venous oxygen saturation ScVO2 normalization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Hepatology & Tropical Medicine Research Institute: lead

Study Sites (1)

NHTMRI

Cairo, Egypt

Location

MeSH Terms

Interventions

Fluid Therapy; Crystalloid Solutions; Sodium Chloride

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Intensive care medicine, Ph D

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: March 6, 2018
• Study Start: August 1, 2018
• Primary Completion: February 15, 2020
• Study Completion: May 15, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations

EG (1)