Respiratory Alterations of Acid-base Equilibrium: Acute and Chronic Renal Response

Acute Respiratory Variations of Acid-base Equilibrium Clinical Trial

Official title:

Respiratory Alterations of Acid-base Equilibrium: Acute and Chronic Renal Response

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01540916
• Other study ID #: 842
• Status: Active, not recruiting
• Phase: N/A
• First received: February 23, 2012
• Last updated: November 7, 2015
• Start date: February 2012
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Alterations of acid-base equilibrium are very common in critically ill patients. Thus, understanding their pathophysiology and the possible compensatory mechanisms acting in different organs may play an important role in better set the consequent clinical treatment. The lung and the kidney are the two principal actors of such regulations. Although the respiratory response to acid-base alterations is well understood, less information are available for what the renal system is concerned. Such lack of information is partially due to: 1) the historical consideration of the kidney as a "slow" organ, in response to variations in acid-base equilibrium; 2) the lack of a monitoring system to closely assess renal response.

Our group has recently developed a monitoring system aimed at analyzing, in a quasi-continuous and non-invasive manner (every 10 min) the urinary profile in terms of urinary pH and electrolyte concentrations (sodium, potassium, chloride, ammonium).

The investigators hypothesize that the renal system reacts to large as well as to minimal variations of the acid-base equilibrium (especially induced by a variation in the respiratory function) in a very fast way, modifying the urinary concentration (and therefore the urinary excretion) of ammonium and some electrolytes (especially chloride).

Description:

Primary aim:

To investigate the acute renal response to respiratory alterations of acid-base equilibrium in order to better understand the underlying physiological mechanisms and to evaluate the validity of a renal monitoring system to indirectly assess the effectiveness of the respiratory function.

Secondary aim:

To collect data on the chronic response of the renal system in patients affected by chronic obstructive pulmonary disease (COPD), as well as on the acute response to acute variation of the chronic respiratory acidosis characterizing patients affected by COPD exacerbation.

Study protol:

Mechanically ventilated patients will undergo controlled variation of the ventilatory setting (hyperventilation vs. hypoventilation) in order to induce a controlled reduction or increase in arterial partial pressure of carbon dioxide (and an increase or reduction of arterial pH), within normal range of pH (7.35 - 7.45) During the variations, urinary concentrations of electrolytes and pH will be monitored.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Presence of mechanical ventilation

2. Presence of arterial and central venous line

3. Presence of urinary catheter

Exclusion Criteria:

1. acute or chronic renal failure with anuria

2. presence of continuous renal replacement therapy

3. hemodynamic instability

4. less than 16 years of age

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acute Respiratory Variations of Acid-base Equilibrium

Intervention

Other:
• Increase minute ventilation
Respiratory rate will be increase in order to have a 30% increase of minute ventilation
• Decrease minute ventilation
Respiratory rate will be decrease in order to have a 30% decrease of minute ventilation

Locations

Country	Name	City	State
Italy	Terapia Intensiva Postoperatoria; Rianimazione Generale - Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variations in urinary electrolyte concentrations and pH		From 0 to 4 hours	No