Dopamine and Norepinephrine Infusion With Restricted Hydration

Renal Function Test, Urine Output, Lactate Level Clinical Trial

Official title:

The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780686
• Other study ID #: ASUH3206/17
• Status: Completed
• Phase: N/A
• Start date: April 9, 2017
• Est. completion date: December 15, 2018

Study information

• Verified date: December 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline infusion only and standard hydration during open abdominal surgeries.

Description:

One hundred and twenty patients were randomly assigned into three groups (dopamine norepinephrine group, restrictive hydration group and liberal hydration group) undergoing open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was introduced according to maintenance, deficit for the first 3 hours (hours fasting x body weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).

The outcome to be assessed was serial measurements of serum lactate intraoperatively and immediate postoperatively as an index of tissue perfusion, in addition to blood pressure, heart rate and oxygen saturation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 15, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• All patients with American Society of Anesthesiologists (ASA) physical status I or II

• Age range from 18-80 years scheduled to either radical cystectomy or hemicolectomy were contained in the study.

Exclusion Criteria:

• Patients with coagulopathies,

• Hepatic dysfunction (prothrombin ratio <50%),

• Renal dysfunction,

• Congestive heart failure (New York Heart Association scores =3),

• Contraindications for epidural analgesia (e.g. patient refusal, local infection or coagulopathy), and peripheral vascular disease.

Related Conditions & MeSH terms

• Renal Function Test, Urine Output, Lactate Level

Intervention

Drug:
• Norepinephrine, dopamine
drugs to decrease bleeding

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum lactate level	Serum lactate level in mmol/l	Before induction of anesthesia and up to 12 hours after.
Primary	Changes in renal function test	Measuring creatinine level	Before induction of anesthesia and up to 12 hours after.